Prosthetic heart valve docking assembly

ABSTRACT

In a representative embodiment, an implantable assembly for a native heart valve comprises a prosthetic heart valve and first and second inflatable bodies. The prosthetic heart valve can comprise a frame and prosthetic leaflets. The first inflatable body can comprise first and second end portions, wherein the first end portion is configured to be secured to tissue of the native heart valve at a first location, and the second end portion is configured to engage an outer surface of the prosthetic valve. The second inflatable body can comprise third and fourth end portions, wherein the third end portion is configured to be secured to tissue of the native heart valve at a second location, and the fourth end portion is configured to engage the outer surface of the prosthetic valve. The first and second inflatable bodies anchor the prosthetic valve within the annulus of the native heart valve.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 62/505,239, filed May 12, 2017, which is incorporatedherein by reference.

FIELD

This disclosure pertains generally to prosthetic devices and relatedmethods for helping to seal native heart valves and prevent or reduceregurgitation therethrough, as well as devices and related methods forimplanting such prosthetic devices.

BACKGROUND

The native heart valves (i.e., the aortic, pulmonary, tricuspid, andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be rendered less effective by congenital malformations,inflammatory processes, infectious conditions, or disease. Such damageto the valves can result in serious cardiovascular compromise or death.For many years the definitive treatment for such disorders was thesurgical repair or replacement of the valve during open-heart surgery.However, such surgeries are highly invasive and are prone to manycomplications. Therefore, elderly and frail patients with defectiveheart valves often went untreated. More recently, transvasculartechniques have been developed for introducing and implanting prostheticdevices in a manner that is much less invasive than open-heart surgery.Such transvascular techniques have increased in popularity due to theirhigh success rates.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps, or leaflets extendingdownward from the annulus into the left ventricle. The mitral valveannulus can form a D-shaped, oval, or otherwise out-of-roundcross-sectional shape having major and minor axes. The anterior leafletcan be larger than the posterior leaflet, forming a generally C-shapedboundary between the abutting free edges of the leaflets when they areclosed together.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates, the oxygenated bloodthat is collected in the left atrium flows into the left ventricle. Whenthe muscles of the left atrium relax and the muscles of the leftventricle contract, the increased blood pressure in the left ventricleurges the two leaflets of the mitral valve together, thereby closing theone-way mitral valve so that blood cannot flow back into the left atriumand is, instead, expelled out of the left ventricle through the aorticvalve. To prevent the two leaflets from prolapse under pressure andfolding back through the mitral valve annulus towards the left atrium, aplurality of fibrous cords called chordae tendineae tether the leafletsto papillary muscles in the left ventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systole phase of the cardiac cycle. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles, and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation, and mitral regurgitation nearer to one commissure (i.e.,location where the leaflets meet) of the leaflets can be referred to aseccentric jet mitral regurgitation.

Some prior techniques for treating mitral regurgitation includestitching portions of the native mitral valve leaflets directly to oneanother. Other prior techniques include the use of a body implantedbetween the native mitral valve leaflets. Despite these priortechniques, there is a continuing need for improved devices and methodsfor treating mitral valve regurgitation.

SUMMARY

This disclosure pertains generally to prosthetic devices and relatedmethods for helping to seal native heart valves, and for preventing orreducing regurgitation therethrough, as well as devices and relatedmethods for implanting such prosthetic devices.

In particular embodiments, the prosthetic device can comprise a body anda fastener. The body can be a relatively thin piece of material thateffectively extends the length and/or width of the native leaflet towhich it is attached. In other embodiments, the body can have sufficientthickness to function as a spacer that is configured to fill the gapalong the coaptation line of the native leaflets. In still otherembodiments, the body can be retained in a collapsed delivery stateinside a delivery catheter during transvacular delivery through apatient's body to the heart and can expand when deployed from thedelivery catheter. In some embodiments, the body also can be configuredto expand radially or laterally to increase the width or diameter of thebody after deployment from a delivery catheter, such as by tensioning asuture extending through the body.

In some embodiments, the body is sufficiently thick to function as aspacer, while also able to effectively extend the length and/or width ofthe native leaflet. The body can be positioned within the native valveorifice to help create a more effective seal between the native leafletsto prevent or minimize mitral regurgitation. The body can comprise astructure that is impervious to blood and that allows the nativeleaflets to close around the body during ventricular systole to blockblood from flowing from the ventricle back into the atrium. The body canfill a gap between improperly functioning native leaflets that do notnaturally close completely.

In some embodiments, the body can effectively extend the leaflet(s)and/or prevent prolapse of the leaflet(s). In some embodiments, the bodycovers a large area of an atrial and/or ventricular surface of theleaflet, such as substantially the entire atrial surface, while in otherembodiments it covers a smaller area. In some embodiments, the body, inparticular, covers the P2 portion of the posterior leaflet of the mitralvalve. The body can cover the entire length of the coaptation line, or aportion thereof. In some embodiments, the body covers the length of thecoaptation line adjacent to the P2 portion of the posterior leaflet.

The body can have various shapes. In some embodiments, the body can havean elongated cylindrical shape having a round cross-sectional shape. Inother embodiments, the body can have an oval cross-sectional shape, arectangular or other polygonal cross-sectional shape, a crescentcross-sectional shape, or various other non-cylindrical shapes. In someembodiments, the body can be substantially flat. The body can have anatrial or upper end positioned in or adjacent to an atrium (such as theleft atrium), a ventricular or lower end positioned in or adjacent to aventricle (such as the left ventricle), and a surface that extendsbetween the native valve leaflets (such as between the native mitralvalve leaflets).

The fastener can be configured to secure the device to one or both ofthe native leaflets such that the body is positioned between two nativeleaflets. The fastener can attach to the body at a location adjacent theventricular end of the body and/or to a location adjacent to the atrialend of the body. The fastener can be configured to be positioned behinda native leaflet when implanted such that the leaflet is capturedbetween the anchor and at least a portion of the body.

Some embodiments disclosed herein are generally configured to be securedto only one of the native mitral leaflets (the posterior or anteriorleaflet). However, in other embodiments, prosthetic devices can besecured to both mitral leaflets. Unless otherwise stated, any of theembodiments disclosed herein can optionally be secured to the anteriormitral leaflet and/or secured to the posterior mitral leaflet,regardless of whether any particular embodiment is shown as beingsecured to a particular leaflet. Moreover, any of the embodiments can beimplanted on one or more native leaflets of the other valves of theheart.

Some embodiments include two or more fasteners, such as to provideadditional stabilization. Unless otherwise stated, any embodiment thatincludes a fastener on the ventricular side can optionally include afastener on the atrial side, regardless of whether or not the particularembodiment is shown with an atrial fastener. Likewise, any embodimentthat includes a fastener on the atrial side can optionally include afastener on the ventricular side, regardless of whether or not theparticular embodiment is shown with a ventricular fastener.

By anchoring a prosthetic mitral device to one of the mitral leaflets,as disclosed herein, instead of anchoring the device to the walls of theleft ventricle, to the walls of the left atrium, to the native valveannulus, and/or to the annulus connection portions of the nativeleaflets, the device anchorage is made independent of the motions of theventricular walls and atrial walls, which move significantly duringcontraction of the heart. Anchoring to a mitral valve leaflet canprovide a more stable anchorage for a prosthetic mitral device, and caneliminate the risk of hook-type or cork-screw-type anchors tearing orotherwise causing trauma to the walls of the left ventricle or leftatrium. Furthermore, the device body can be held in a more consistentposition with respect to the mitral leaflets as the leaflets articulate,eliminating undesirable motion imparted on the device from thecontraction motions of the left ventricle walls and left atrium walls.Anchoring to a mitral leaflet can also allow for a shorter body lengthcompared to devices having other anchorage means.

In a representative embodiment, an implantable prosthetic heart valvedevice comprises an elongated body having first and second end portions,the body being configured to be implanted around a native leaflet of aheart valve such that the first end portion is on an atrial side of theleaflet and the second end portion is on a ventricular side of theleaflet and such that the body can coapt with and move away from anopposing native leaflet during operation of the heart valve. The devicefurther comprises a fastener configured to be mounted on a suture thatextends from one of the first or second end portions, through the nativeleaflet and through the other of the first or second end portions suchthat the body is secured to the native leaflet.

In some embodiments, the body comprises an intermediate portionextending between the first and second end portions, the body beingconfigured such that the intermediate portion extends beyond a free endof the native leaflet when the body is secured to the native leaflet. Insome embodiments, at least one of the first and second end portions ofthe body comprises one or more barbs that can penetrate the nativeleaflet.

In some embodiments, the body of the prosthetic device comprises atubular layer defining a lumen extending from the first end portion tothe second end portion. In some embodiments, the tubular layer has across-sectional profile in a plane perpendicular to the length of thetubular layer, the cross-sectional profile having a major lateraldimension and minor lateral dimension that is smaller than the majorlateral dimension. In some embodiments, the tubular layer comprises atubular braided layer. In some embodiments, the braided layer comprisesa first, inner braided layer and a second, outer braided layer extendingover the inner braided layer, the outer braided layer being relativelyless porous to blood than the inner braided layer.

In another representative embodiment, an assembly comprises an elongatedflexible rail having first and second ends and a length sufficient toform a loop that extends into a patient's body and through a nativeleaflet of a heart valve with the first and second ends outside of thepatient's body. The assembly further comprises an elongated catheter andan implantable prosthetic device configured to be implanted on thenative leaflet, the prosthetic device being coupled to the rail and thecatheter such that advancing the catheter along the rail is effective toadvance the prosthetic device to the native leaflet. The prostheticdevice can be configured such that when it is implanted on the nativeleaflet, the prosthetic device can coapt with and move away from anopposing native leaflet during operation of the heart valve.

In another representative embodiment, a method comprises implanting aflexible rail in the heart of a patient's body such that the rail formsa loop that extends through a leaflet of the native heart valve andfirst and second ends of the rail reside outside of the patient's body;coupling a prosthetic device to the rail and delivering the prostheticdevice to the native leaflet via the rail; and securing the prostheticdevice to the native leaflet.

In another representative embodiment, a method comprises inserting anelongated catheter into a patient's body; advancing the catheter throughthe patient's body into the heart; penetrating a native heart valveleaflet with a distal end portion of the catheter; inserting anelongated rail through the catheter such that a distal end of the railextends through the native leaflet; and pulling the distal end of therail outside of the patient's body such that the rail forms a loopextending through the native leaflet.

In another representative embodiment, an assembly comprises a firstcatheter configured to be inserted into a patient's body and having adistal end portion that can be guided to a position adjacent a nativeleaflet of a heart valve. A second catheter is configured to extendthrough the first catheter and has a distal end portion configured toextend through the native leaflet. An elongated rail is configured toextend from a location outside the patient's body, through the secondcatheter, and through the native leaflet. A snare catheter is configuredto extend through the second catheter, and comprises a snare loop at adistal end thereof configured to capture a distal end of the rail thatextends through the native leaflet and retract the distal end of therail back into the first catheter.

In some embodiments, one or more expandable or inflatable implantablebodies can be secured to the leaflets and/or the annulus of a nativeheart valve and used to anchor a prosthetic heart valve within theannulus. In one representative embodiment, an implantable assembly for anative heart valve comprises a prosthetic heart valve and first andsecond inflatable bodies. The prosthetic heart valve can comprise aframe and prosthetic leaflets. The first inflatable body can comprisefirst and second end portions, wherein the first end portion isconfigured to be secured to tissue of the native heart valve at a firstlocation, and the second end portion is configured to engage an outersurface of the prosthetic valve. The second inflatable body can comprisethird and fourth end portions, wherein the third end portion isconfigured to be secured to tissue of the native heart valve at a secondlocation, and the fourth end portion is configured to engage the outersurface of the prosthetic valve. The first and second inflatable bodiesanchor the prosthetic valve within the annulus of the native heartvalve.

In another representative embodiment, a method comprises implantingfirst and second inflatable bodies within an annulus of a native heartvalve, and implanting a prosthetic heart valve between the inflatablebodies such that the prosthetic heart valve is retained within theannulus by the inflatable bodies.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross section of a heart with a prosthetic device fortreating mitral valve regurgitation implanted on the posterior mitralvalve leaflet, according to one embodiment.

FIGS. 2A-2F show a method of implanting via a transfemoral approach asuture that extends through the left ventricle and the posterior leafletfor subsequent implantation of the prosthetic device shown in FIG. 1.

FIGS. 3A-3H show the implantation of the prosthetic device of FIG. 1being implanted along the suture shown in FIGS. 2A-2F.

FIG. 4 shows a cross section of a heart with a prosthetic device fortreating mitral valve regurgitation implanted on the posterior mitralvalve leaflet, according to another embodiment.

FIG. 5 shows a cross section of the left side of a heart with aprosthetic device for treating mitral valve regurgitation implanted onthe posterior mitral valve leaflet, according to another embodiment.

FIGS. 6 and 7 show front and perspective views of a prosthetic devicefor treating mitral valve regurgitation, according to anotherembodiment.

FIGS. 8-10 show perspective and side views a prosthetic device fortreating mitral valve regurgitation implanted on the posterior mitralvalve leaflet, according to another embodiment.

FIG. 11 shows a cross section of the left side of a heart withprosthetic devices for treating mitral valve regurgitation implanted onthe posterior and anterior mitral valve leaflets, according to anotherembodiment.

FIG. 12 shows a cross section of the left side of a heart withprosthetic devices for treating mitral valve regurgitation implanted onthe posterior and anterior mitral valve leaflets, according to anotherembodiment.

FIGS. 13A-13D are cross sections of a heart showing another method ofimplanting a prosthetic device for treating mitral valve regurgitationon the posterior mitral valve leaflet.

FIGS. 14A-14E show alternative ways of securing the prosthetic deviceshown in FIG. 13A-13D.

FIGS. 15A-15B are cross sections of a heart showing the implantation ofa suture through the posterior mitral valve leaflet, according toanother embodiment.

FIGS. 16A-16B are cross sections of a heart showing the implantation ofa suture through the posterior mitral valve leaflet, according toanother embodiment.

FIGS. 17A-17C are cross sections of a heart showing various ways ofimplanting a suture through the anterior mitral valve leaflet.

FIGS. 18A-18F are cross sections of a heart showing a method ofimplanting a suture transseptally through the posterior mitral valveleaflet, and implanting a prosthetic device at the posterior mitralvalve leaflet using the suture, according to another embodiment.

FIG. 19 a cross section of a mitral valve with a prosthetic device fortreating mitral valve regurgitation with increased stiffness to aid invalve patency, according to one embodiment.

FIG. 20 shows decreased leakage rates for mitral valves fitted withprosthetics disclosed herein.

FIG. 21 shows a cross section of a heart with an example of a suturerail extending from the inferior vena cava transseptally through theposterior leaflet of the mitral valve.

FIG. 22 is a side view of a delivery catheter for use in implanting asuture rail through native valve tissue, according to one embodiment.

FIG. 23 is a side view of an embodiment of a lasercut tube that can beused in the steerable section of the delivery catheter shown in FIG. 22.

FIG. 24 is a cross sectional view of the delivery catheter of FIG. 22taken along line 24-24.

FIG. 25 is an enlarged side view of the shaft of the delivery catheterof FIG. 22.

FIG. 26 is a perspective view of an embodiment of a crossing-catheterthat can be used with the delivery catheter of FIG. 22 to implant asuture rail through native valve tissue.

FIG. 27 is a perspective view of an embodiment of a needle wire forpuncturing native valve tissue.

FIGS. 28 and 29 are perspective views of two different embodiments of asnare catheter that can be used with the delivery catheter of FIG. 22when implanting a suture rail through native valve tissue.

FIG. 30 is a side view of an embodiment of a suture-feeding device thatcan be used to advance a suture rail through a delivery catheter.

FIG. 31A-31H show cross sections of a heart showing the implantation ofa suture rail through the posterior leaflet of the mitral valve leafletusing the tools shown in FIGS. 22-29.

FIGS. 32A-32D are various views of another embodiment of a prostheticdevice for treating mitral valve regurgitation.

FIGS. 33A-33C are additional views of the prosthetic device shown inFIGS. 32A-32D.

FIG. 34 is a perspective view of another embodiment of a prostheticdevice for treating mitral valve regurgitation shown being advancedalong a suture rail.

FIG. 35 is a cross sectional view of the mitral valve showing theimplantation of the prosthetic device of FIG. 34.

FIG. 36 is a side view of the prosthetic device of FIG. 34 shown in thedeployed state.

FIGS. 37 and 38 are enlarged views of the proximal end portion of theprosthetic device shown in FIG. 34.

FIG. 39 is a cross sectional view of the mitral valve showing theimplantation of the prosthetic device of FIG. 34.

FIG. 40 is an enlarged view of the proximal and distal end portions ofthe prosthetic device of FIG. 34 after the device is deployed around anative leaflet.

FIG. 41 is a cross sectional view of the mitral valve showing theprosthetic device of FIG. 34 deployed around the native posteriorleaflet.

FIG. 42 is a perspective view of an embodiment of a delivery catheterand the prosthetic device of FIG. 34 coupled to the delivery catheterfor delivery to a native leaflet.

FIG. 43 is an enlarged view of the distal end portion of the deliverycatheter and the prosthetic device shown in FIG. 42.

FIG. 44 is a perspective, cross sectional view of the distal end portionof the delivery catheter shown in FIG. 42.

FIG. 45A is a cross sectional view of the delivery catheter of FIG. 42.

FIG. 45B is an enlarged cross sectional view of the distal end portionof the delivery catheter of FIG. 45A.

FIG. 45C is a cross sectional view of the delivery catheter of FIG. 45Btaken along line FIG. 45C-45C.

FIG. 46A-46C are various views of another embodiment of a prostheticdevice for treating mitral valve regurgitation.

FIGS. 47 and 48 are end views of two different embodiments of anuntwisting catheter that can be used to untwist a suture rail extendinginto a patient's vasculature.

FIGS. 49A-49C are cross sectional views showing the use of theuntwisting catheter of FIG. 47 or FIG. 48.

FIG. 50 is a side view of another embodiment of a prosthetic device fortreating mitral valve regurgitation.

FIG. 51 shows the prosthetic device of FIG. 50 implanted on a nativeleaflet.

FIG. 52 shows a modification of the prosthetic device of FIG. 50.

FIGS. 53 and 54 are end view and bottom views, respectively, of anotherembodiment of a prosthetic device for treating mitral valveregurgitation.

FIGS. 55A-55E show a method for implanting a prosthetic heart valve inthe mitral position using a prosthetic device mounted on one of thenative leaflets as a support structure for the prosthetic valve.

FIGS. 56A-56E show another method for implanting a prosthetic heartvalve in the mitral position using two prosthetic devices mounted on thenative leaflets as a support structure for the prosthetic valve.

FIGS. 57A-57D show another method for implanting a prosthetic heartvalve in the mitral position using a rail extending through one of thenative leaflets as a support structure for the prosthetic valve.

FIGS. 58A-58E show another method for implanting a prosthetic heartvalve in the mitral position using a prosthetic device mounted on one ofthe native leaflets as a support structure for the prosthetic valve.

FIG. 59 is a side view of another embodiment of a prosthetic device fortreating mitral valve regurgitation.

FIGS. 60, 61A, and 61B show an exemplary docking assembly for aprosthetic heart valve, according to one embodiment.

FIG. 62 shows an exemplary docking assembly for a prosthetic heartvalve, according to another embodiment.

FIGS. 63-64 show an exemplary docking assembly for a prosthetic heartvalve, according to another embodiment.

FIG. 65 shows an exemplary docking assembly for a prosthetic heartvalve, according to another embodiment.

FIG. 66 shows an exemplary docking assembly for a prosthetic heartvalve, according to another embodiment.

DETAILED DESCRIPTION

Described herein are embodiments of prosthetic devices that areprimarily intended to be implanted at one of the mitral, aortic,tricuspid, or pulmonary valve regions of a human heart, as well asapparatuses and methods for implanting the same. The prosthetic devicescan be used to help restore and/or replace the functionality of adefective native mitral valve. The disclosed embodiments should not beconstrued as limiting in any way. Instead, the present disclosure isdirected toward all novel and nonobvious features and aspects of thevarious disclosed embodiments, alone and in various combinations andsub-combinations with one another.

FIG. 1 shows a cross sectional view of the heart with a prostheticdevice 100 secured to a posterior leaflet 8 of the mitral valve,according to one embodiment. The device can comprise a body 102 (whichmay be ribbon-like as shown), a fastener 104 (e.g., a suture clip shownon the ventricular side in this example and therefore can be referred toas a ventricular-side fastener), and a length of suture 106 extending(at least) between the body 102 and the fastener 104 through theposterior leaflet 8. The body 102 can be wrapped around the leaflet suchthat a first end portion 108 of the body 102, fixedly engaged to suture106, covers an atrial surface of the leaflet 8, while a second endportion 110 covers a ventricular surface of the leaflet 8. The suture106 can extend from the fastener 104 through, in order, the second endportion 110, the leaflet 8, and the first end portion 108. In oneembodiment, the fastener 104 can be positioned at the P2 region of theposterior leaflet 8.

The fastener 104 can be a suture clip, or another type of fastener thatcan be deployed from a catheter and secured to a suture within thepatient's body. Various suture clips and deployment techniques forsuture clips that can be used in the methods disclosed in the presentapplication are disclosed in U.S. Publication Nos. 2014/0031864 and2008/0281356 and U.S. Pat. No. 7,628,797, which are incorporated hereinby reference. In the case of a slidable fastener, the fastener 104 canbe movable along the suture 106 in the direction of the posteriorleaflet 8, and configured to resist movement along the suture 106 in theopposite direction.

The body 102 is configured to treat or minimize mitral regurgitation bypromoting coaptation with the opposing leaflet (in this case, theanterior leaflet). For example, the first end portion 108 (in thisexample on the atrial side) can have a thickness sufficient to serve asa gap filler to treat or prevent mitral regurgitation. In someembodiments, the entire body 102 has a substantially the same thickness.In other embodiments, at least one portion or section of the body 102has a different thickness than another portion or section, for example,thicker at a central region and thinner at the first end portion 108 andsecond end portion 110.

Some embodiments in which a portion of the body 102 is relativelythicker at a region that coapts with the opposite leaflet, the anteriorleaflet in FIG. 1, exhibit improved coaptation therewith. The device 100also can effectively extend the length of the native leaflet to promotecoaptation, which can be useful to treat or prevent functional mitralregurgitation (FMR). In this manner, the prosthetic device 100 (andother prosthetic devices disclosed herein) augments the overall size andthe normal operation of the native leaflet on which it is mounted. Thus,the prosthetic device 100 (and other prosthetic devices disclosedherein) can be referred to as a prosthetic leaflet augmenting device.

The device 100 can be centered between the two bundles of chordaetendons below the mitral valve. In various embodiments, the device 100geometry can vary to address the particular geometry of the diseasednative mitral valve, including any pathological changes to thecoaptation line.

The body 102 of the device 100 can be made from any of various suitablematerials, including but not limited to, ePTFE (Gore-Tex®), silicone,polyurethane, PET (polyethylene terephthalate), or other polymericmaterials, or biological materials, such as pericardial tissue, orcomposites thereof.

FIGS. 2A-2F illustrate the placement of an exemplary loop or raildelivery system 30 (for example, via a transfemoral approach) forsubsequent introduction of the device 100 into the heart. The loopdelivery system 30 can comprise an outer catheter 32, an inner catheter34 extending through a lumen of the outer catheter 32, and a rail in theform of a guide suture 36 extending through the outer catheter 32 andinner catheter 34. The rail 36 can comprise any kind of flexiblematerial, including conventional suture material or a metal wire (suchas used for a conventional guide wire) and is used for subsequentdelivery of the prosthetic device, as described in detail below.

The loop delivery system 30 (including outer catheter 32) can first beadvanced, for example, through the femoral artery, into the patient'sleft ventricle via the aorta and the aortic valve, as shown in FIG. 2A.Once the outer catheter 32 has been advanced into the left ventricle,the inner catheter 34 can be advanced to extend past the distal end ofthe outer catheter 32 towards the posterior leaflet (FIG. 2B). Thedistal end of the inner catheter 34 can comprise a hollow needle 38 topenetrate through the native leaflet, annulus, or muscle tissue. Theinner catheter 34 can be advanced to abut the ventricular side of theposterior leaflet 8 (such as at the P2 position), such that, withadditional force, the needle 38 can pierce the leaflet 8 and create anopening in the leaflet 8. The inner catheter 34 can then be furtheradvanced such that a distal end of the inner catheter 34 can extendthrough the opening. In some embodiments, the inner catheter 34 and/orthe outer catheter 32 are sufficiently stiff to promote piercing of theleaflet 8.

As shown in FIG. 2C, the suture 36 can then be advanced distally out ofthe inner catheter 34 and into the left atrium (FIG. 2C). In someembodiments, the suture 36 can run through an interior lumen of theinner catheter and the needle. In other embodiments, the needle 38 isnot hollow and/or the suture 36 does not extend through the needle 38.In some embodiments, a portion of the guide suture 36 is releasablyattached to an interior surface of the inner catheter 34 duringplacement of the suture 36.

As shown in FIG. 2D, a separate snare catheter 40 can then be inserted,for example, transfemorally, into the heart to capture the leading endof the suture 36. Alternatively, the snare catheter 40 extends through alumen of the outer catheter 32 and is advanced distally out from theouter catheter 32 in ensnaring the suture 36. The snare catheter 40 canbe manipulated to enter the left ventricle and then to cross the mitralvalve into the left atrium to capture the suture 36, (e.g., bypositioning a loop at the end of the snare catheter around the endportion of the suture 36). The snare catheter 40 can then be retractedto pull the suture 36 between the leaflets of the mitral valve (FIG.2E), into the left ventricle, and out the patient's body, for example,via the femoral artery (FIG. 2F). In some embodiments, the snarecatheter 40 (with the captured suture 36) can be configured to be pulledinto the outer catheter 32. In alternative embodiments, the snarecatheter 40 and the outer catheter 32 can be deployed from a commoncatheter that extends into the aorta or the left ventricle. In stillother embodiments, the snare catheter 40 can be deployed from a separateouter catheter that extends into the aorta or the left ventricle.

The inner and outer catheters 32, 34 can then be withdrawn, leavingbehind a loop of guide suture 36 (FIG. 2F). In particular, the loop ofsuture 36 can enter the left ventricle via the aortic valve, extendthrough the posterior leaflet 8 from the ventricular side, and extendinto the left atrium, before then looping back into the left ventriclevia the mitral valve and exiting via the aortic valve. In various otherembodiments, the directionality of the loop delivery system 30 can bereversed (i.e., the suture 36 enters the posterior leaflet from theatrial side and extends into the left atrium). Moreover, it should benoted that the suture 36 need not extend through the native leaflet andinstead can extend through the native mitral valve annulus (desirably ator adjacent the P2 position) or through the muscle behind the nativeannulus (desirably at or adjacent the P2 position). Thus, for any of theembodiments disclosed herein, a guide rail (e.g., a suture) can beimplanted to extend through a native leaflet, a native valve annulus, orthe muscle behind the native valve annulus.

FIGS. 3A-3G illustrate an exemplary process of introducing andimplanting the device 100 into a left ventricle of the heart. As shownin FIG. 3A, a first end segment 42 of the suture 36 (outside of thepatient) can be configured to fixedly engage the first end portion 108of the body 102. Also, a second end segment 44 of the suture 36 (alsooutside of the patient) can be configured to extend through the secondend portion 110 of the body 102. In particular, the second end segment44 can extend through a small opening or aperture in the body 102, whichis small enough such that substantial blood cannot flow therethrough.Then, as shown in FIG. 3B, the body 102 and both suture end segments 42,44 can be enclosed within a delivery catheter 50 for delivery to theheart. In some embodiments, the body 102 can be contained in acompressed state within the catheter 50. For example, the body 102 canbe resiliently deformed in this compressed configuration, such that thebody 102 resiliently returns to the configuration shown in FIG. 3A whenreleased from constraint. The second end segment 44 can extend out theproximal end of the catheter, outside of the patient, and is thusavailable for manipulation during the process of installing the device100. The suture 36 can thus be used to guide the delivery of the device100 and other delivery components to an appropriate location within apatient's vasculature.

As shown in FIG. 3C, the delivery catheter 50 can be advanced into theleft ventricle. Once a distal end of the catheter 50 is within the leftventricle, an inner catheter or pusher member 52, configured to extendthrough the delivery catheter 50 proximal to the body 102, can beadvanced to advance the device 100 out of the delivery catheter 50. Invarious embodiments, the delivery catheter 50, inner catheter 52, andguide suture 36 can be independently retracted proximally or extendeddistally with respect to one another. The inner catheter 52 can operateas a pusher, urging the device 100 distally along the suture 36. Theinner catheter 52 can be used to urge the device 100 distally along thesuture 36 in the direction of the native mitral valve (FIGS. 3D-3E).

The second end segment 44 of the suture 36 (extending outside of thepatient) can be pulled simultaneously and/or in tandem with advancementof the delivery catheter 50 and/or the inner catheter 52. This pullingof the second end segment 44 pulls the suture loop 36 through the body102 as the body is advanced distally toward the posterior leaflet 8.Pushing the body 102 while pulling the suture loop brings the body 102into a suitable orientation for installation at the posterior leaflet 8(FIG. 3F). Ultimately, as shown in FIG. 3G, the first end portion 108can be brought adjacent to the atrial side of the posterior leaflet 8,while the second end portion 110 can be brought adjacent to theventricular side.

Once the body 102 is in its final, operating position, the device 100can be secured in place using the fastener 104 (FIGS. 3G-3H), which canbe deployed from the inner catheter 52, the outer catheter 50, or aseparate catheter. As shown in FIGS. 3F-3G, the fastener 104 can beseated at a distal end of the inner catheter 52 to eventually fix thedevice 100 in place on the posterior leaflet 8 once positioned. Theouter and inner catheters 50, 52 can then be retracted from the site ofimplantation within the heart and removed from the patient (FIG. 3H).

In some embodiments, placement of the body 102 can be reversed duringdelivery, such that first end segment 42 of the suture 36 (and the firstend portion 108 of the body 102) can be brought against the ventricularside of the leaflet 8, and the second end segment 44 of the suture 36(and the second end portion 110 of the body 102) can be brought againstthe atrial side. In some embodiments, this reversal of placement isaccomplished simply by reversing the orientation of the body 102 duringloading onto the sutures 36, for example, in the step illustrated inFIG. 3A. FIGS. 18A-18E show an exemplary process for delivering the body102 transseptally, for example, from the right atrium, through theatrial septum, and into the left atrium, which results in such aconfiguration.

As shown in FIG. 18A, the outer catheter 32 and/or inner catheter 34 canbe inserted into the left atrium transseptally, and the inner catheter34 can bring the suture 36 between the leaflets 6, 8 of the mitral valveinto the left ventricle, and then through the posterior leaflet 8 backinto the left atrium. The snare catheter 40 (which also can extendthrough the outer catheter 32) can be inserted transseptally to capturethe suture 36 and bring it outside of the patient's body. The body 102can then be loaded on the suture 36 (FIG. 18B) and delivered to theposterior leaflet 8 (FIGS. 18C and 18D). As shown in FIGS. 18D-18E, thefastener 104 can also be located on the atrial side of the leaflet 8,and the installed suture length 106 can extend from the fastener 104through, in order, the first end portion 108 of the body, the posteriorleaflet 8, and the second end portion 110.

FIG. 18F shows that the tension in the suture 106 can be adjusted toaffect the position of the first end portion 108 of the implant. In FIG.18F, the suture 106 is not pulled tight to pull the first end portion108 against the ventricular side of the posterior leaflet 8. Instead, asufficient degree of slack in the suture 106 allows the first endportion 108 to hang or “float” below the posterior leaflet. Also, thetension of the suture 106 can be adjusted to fit the device 100 to thesize of the native leaflet 8. In this manner, the device 100 has thebenefit of being a “one-size-fits-all” and/or otherwise adaptable to fitaround leaflets of varying sizes and/or geometries.

FIGS. 4-7 show an alternative device 200 comprising a body 202 accordingto another embodiment, wherein the body 202 is coupled to one of thenative leaflets using, for example, suture. The body 202 can be formedfrom any of various suitable materials, including bio-compatiblematerials such as pericardial tissue, polymer, sponge, foam, gel, or agel or saline filled structure such as a balloon. The materialcomposition of the body 202 can be selected to increase desirablecharacteristics of the body 202, such as performance, durability,promotion of native tissue in-growth, etc. The body 202 can be formed inany of various suitable shapes, such as a rectangle, a semi-ellipticalring or U-shape, or a semi-ellipse. As shown in FIG. 4, the body 202 canbe sutured to the posterior leaflet 8 using suture(s) 206 via atransseptal approach. Alternatively, as shown in FIG. 5, the body 202can be sutured to the posterior leaflet 8 using suture(s) 206 via atransapical approach. In use, the opposite leaflet (the anterior leafletin the illustrated embodiment) can coapt against the body 202 toprevent, reduce, or minimize regurgitation.

FIG. 6 shows the body 202 after suturing to the native posterior leaflet8. In this embodiment as shown, two sutures 206 can be sufficient tocouple the body 202 to the leaflet 8. The sutures 206 can be positionedas shown, with one suture 206 at either end of the body 202, which spansa width of the leaflet 8. In other embodiments, additional or fewersutures can be used, and the sutures can be situated in alternativelocations on the body 202 and/or on the leaflet 8.

FIG. 7 shows an embodiment of a method for coupling the body 202 to theposterior native leaflet 8 using a length of elongate material 206 and apair of fasteners in the form of slidable locking devices 208. Theelongated material 206 can comprise, for example, a length of thread orsuture material, or a metal or polymeric wire, or any other materialsuitable for suturing, such as biological tissue. In the illustratedembodiment, a single strand of material 206 is used, although inalternative embodiments, two or more strands 206 can be used to couplethe body 202 to the native leaflet 8.

In order to couple the body 202 to the native posterior leaflet 8, oneor both of the slidable locking devices 208 can be guided along thestrand of material 206 toward the native leaflet 8, thereby decreasingthe length of the strand 204 between the locking devices 208 until thebody 202 is held firmly against the leaflet 8 in a desired deployedconfiguration. Because the locking devices 208 are positioned behind theposterior leaflet 8 in this configuration (that is, they are locatedbetween the native leaflet 8 and the wall of the left ventricle 2), thepotential for interference between the locking devices 208 and thecoaptation region of the leaflets is minimized Once the body 202 issituated in this configuration, any excess material 210 can be trimmedto prevent the material 206 from interfering with the operation of theheart valve. The locking devices 208 can be configured to slide or passover a suture in one direction and to resist movement in the oppositedirection. Examples of locking devices (also referred to as suturesecurement devices) that can be implemented in the embodiment of FIG. 7are disclosed in U.S. Publication No. 2014/0031864, which isincorporated herein by reference.

As discussed above, FIGS. 4-7 show a body 202 coupled or secured to theposterior leaflet 8. In alternative embodiments, a body 202 can becoupled as described above to the anterior leaflet in place of or inaddition to the body 202 coupled to the posterior leaflet 8.

FIGS. 8-10 show another exemplary device 300, which can be implanted atthe mitral valve region for treatment of mitral regurgitation. Thedevice 300 can comprise a strong, flexible sheet of blood-impermeablematerial. The device 300 can have a body 301 with an upper, first endportion 302 that is secured to the mitral annulus and/or the region of amitral valve leaflet adjacent to the mitral annulus. The portion of thebody 301 extending away from this first end portion 302 is a free endportion of the body 301. In the illustrated example, the first endportion 302 is attached to the mitral annulus above the posteriorleaflet 8. In other examples, the arrangement can be reversed with thedevice 300 secured to an anterior leaflet 6. The device 300 can besecured to the native tissue by various means, such as suture, barbedanchors, and/or microanchors 318. The first end portion 302 of the body301 can be wider than the free end portion of the body 301, and thus thebody 301 can have a generally trapezoidal shape.

In FIG. 8, the lower end of the anterior leaflet 6 is not shown in orderto show the lower end of the posterior leaflet 8 and a lower, second endportion 306 of the device 300 extending downwardly through the mitralorifice and into the left ventricle 2. The second end portion 306 of thedevice can be shorter, longer, or about the same length as the leafletto which it is attached. As shown in FIGS. 9 and 10, the second endportion 306 of the device in the illustrated embodiment can extend belowthe lower end of the posterior leaflet during diastole (FIG. 10), andextends short of the lower end of the anterior leaflet 6 during systole(FIG. 9).

The second end portion 306 can be tethered to a location in the leftventricle 4. For example, the second end portion 306 can be tethered tothe papillary muscle heads 310 via tethers 308 (which can be made of,for example, suture material) and anchors 312, as shown, (similar to themanner in which the native chordae tendineae 314 tether the nativeleaflet 8 to the papillary muscles 310), and/or can be tethered to theapex of the left ventricle 4.

During systole, as shown in FIG. 9, the device 300 inflates or fillswith blood from the left ventricle 4 and expands laterally toward theanterior leaflet 6. This expansion causes the lower portion of thedevice 300 to seal against the anterior leaflet 6, thereby blocking theflow of blood back into the left atrium 2. The lateral edges of thedevice 300 can seal between the two native leaflets adjacent to thecommissures where the native leaflets still naturally coapt with eachother. The tethers 308 prevent the second end portion 306 of the device300 from moving toward and/or into the left atrium 2 and therebybreaking the seal with the anterior leaflet 6. Thus, the device 300augments the native posterior leaflet and helps seal the mitral orificein the case where the native leaflets 6, 8 do not otherwise not fullycoapt, thereby allowing regurgitation therebetween.

During diastole, as shown in FIG. 10, the device 300 collapses againstthe posterior leaflet 8, allowing blood to flow from the left atriuminto the left ventricle 4 with minimal obstruction from the device 300.

FIG. 11 shows embodiments of prosthetic devices 400, 402 that can beused to extend the effective lengths of the native leaflets 6, 8. Theprosthetic devices 400, 402 can comprise bodies 404, 406 and one or moresutures 412 for coupling each body 404, 406 to a respective anterior orposterior native leaflet 6, 8. In use, the bodies 404, 406 have free endportions 408, 410 extending away from the ends of the native leaflets,extending the effective lengths of the native leaflets, therebyincreasing the chance of and extent of coaptation between them, asdescribed more fully below.

The bodies 404, 406 can comprise a material that is sufficiently stiffto reduce leaflet prolapse, and sufficiently flexible to increase theextent of leaflet coaptation. Suitable materials can include, forexample, biological materials such as pericardial tissue, ePTFE(Gore-Tex®), silicone, polyurethane, PET, or other polymeric materials,or composites thereof. FIG. 11 shows that a device 400, 402 can be usedon each of the anterior and posterior native leaflets 6, 8, but inalternative embodiments, only one such device can be used. In someembodiments, tethers can be used to tether free end portions of thebodies 404, 406 to locations in the left ventricle 4, thus reducing thechances of prolapse of the prosthetic devices 400, 402 during systole.

FIG. 12 shows exemplary prosthetic devices 500, 502 which combinefeatures of the prosthetic bodies described above. The prosthetic device500 is shown coupled to the posterior native leaflet 8, while theprosthetic device 502 is shown coupled to the anterior native leaflet 6.The prosthetic devices 500, 502 include relatively thick upper portions504, 506 and relatively thin, elongate free end portions 508, 510, whichfunction in a manner similar to the devices 300, 400, 402 describedabove. The free end portions 508, 510 can have respective distal endportions 514, 516, which represent the effective distal ends of theextended leaflets.

In use, the free end portions 508, 510 extend the effective lengths ofthe respective leaflets, and can facilitate initiation of leafletcoaptation during ventricular systole. During systole, the leaflets areurged toward one another due to the pressures extant in the leftventricle 4 and left atrium 2. Due to the extended effective length ofthe leaflets, the distal end portions 514, 516 are more likely to coaptthan the ends of the native leaflets absent the extensions. Oncecoaptation is initiated, and thus blood flow from the left ventricle 4to the left atrium 2 at least partially impeded, the pressure in theleft ventricle 4 can increase, further increasing the pressuredifferential between the left ventricle 4 and the left atrium 2, thusfurther urging the leaflets 6, 8, towards one another.

As a result, the portions of the leaflets 6, 8, and their respectiveextensions 502, 500 which coapt, increases (both in the direction fromthe distal end portions 514, 516 toward the left atrium 2, and from thelocations of the devices 500, 502, toward the commissure points of themitral valve), leading to a cycle of increasingly impeded blood flow,increased pressure differential, and increased coaptation of theleaflets. Thus, by facilitating initiation of coaptation, the free endportions 508, 510 can help to reduce regurgitation of blood from theleft ventricle 4 to the left atrium 2 during ventricular systole.Further, the upper portions 504, 506 can further help to preventregurgitation in the manner described above with respect to prostheticdevices 100, 200, 300, 400, 402.

FIG. 12 shows that the devices 500, 502 can be sutured to the nativeleaflets 8, 6, with sutures 512, but in alternative embodiments, thedevices 500, 502 can be clipped or otherwise fastened to the nativeleaflets 8, 6. In alternative embodiments, only one of the devices 500,502 can be used rather than both.

FIGS. 13A-13D show an embodiment of an exemplary process for introducingthe device 300 (which can also be used for implanting devices 200, 400,402, 500, 502 described above). First, a loop delivery system can beused, as described above with respect to the introduction of device 100,to run a suture 36 into the left ventricle, through the posteriorleaflet 8, and into the left atrium. As with device 100, the first endsegment 42 of the looped suture 36 can be fixedly attached to a firstend portion 302 of the body 301. However, unlike with the device 100,the second end segment 44 of the suture 36 does not extend through thesecond end portion 306 of the body 301. That is, the second end portion306 is not attached to the suture 36 and thus the second end portion 306need not comprise an opening for a suture, a guidewire, or the like.

Once the guide suture 36 is in place, the device 300 can be advancedalong the suture 36 into the left ventricle and into the vicinity of thenative mitral valve using outer and inner catheters 32, 34 as describedabove. During delivery, the delivery catheter 50 can sit adjacent andproximal to the second end portion 306 of the body 301. Once ejectedfrom the catheter 50 in the vicinity of the native mitral valve, thebody 301 can be positioned as shown in FIG. 13B, with the first endportion 302 positioned in the atrium, in the vicinity of the atrial sideof the posterior leaflet 8 (such as near the P2 position) and the secondend portion extending through the mitral valve into the left ventricle.To promote this placement, the suture 36 can be tightened by pulling onthe second end segment 44 (in the direction of the arrows as shown inFIG. 13B, simultaneously and/or in tandem with advancing the deliverycatheter 50 and/or inner pusher catheter 52) to bring the first endportion 302 against the atrial side of the posterior leaflet 8 (FIGS.13B-13C). The fastener 304 can then be deployed to secure the device 300in place at the posterior leaflet 8. Finally, the suture 36 can be cutproximal to the fastener 304, and the catheters 50, 52 can be withdrawn(FIG. 13D).

FIGS. 14A-14E show various alternative means for fastening the device300 to location(s) within or along the heart. FIG. 14A shows the device300 fastened to the ventricular wall, with the fastener 304 locatedalong an external lateral surface of the heart. The implanted suture 308can extend through the heart muscle, into the left ventricle and acrossthe posterior leaflet 8. FIG. 14B shows the fastener 304 instead locatedoutside the heart at the left ventricular apex. In FIG. 14C, thefastener 304 fixes the first end portion 302 to the posterior leaflet 8,while a suture or tether 308 connects the second end portion 306 to ananchor 312 attached to a papillary muscle head 310.

In various embodiments, the methods of delivering the device 300 mayvary, such that the sutures can run in the directions shown. In someembodiments, the device 300 can be delivered via a transapical or otherapproach that extends directly through a wall of the heart from theoutside of the heart. In some embodiments, as shown in FIG. 14D, therecan be two (or more) implanted sutures 308 extending through a singlefastener 304 attached to the ventricular side of the posterior leaflet.In some embodiments, as shown in FIG. 14E, there can be two (or more)fasteners 304 attached to the ventricular side of the posterior leaflet,which can be delivered along two or more suture loops 36.

FIGS. 15A-15B shows an embodiment of an alternative process fordelivering a suture or rail 36 into the heart. The catheters 32, 34 canbring the suture 36 transfemorally through the aortic valve into theleft ventricle, across the posterior leaflet 8, and into the leftatrium. The snare catheter 40 can then be inserted into the right atrium(such as via the superior vena cava), then transseptally across theatrial septum (FIG. 15A) into the left atrium to capture a leading endof the suture 36 and bring it back outside the patient's body, leavingbehind a suture loop as shown in FIG. 15B for subsequent devicedeployment.

As discussed, in some embodiments, the snare catheter 40 can emerge fromthe outer catheter 32, whereas in other embodiments the snare catheter40 is separate from the delivery catheter. In some embodiments, thedirectionality of suture loop 36 delivery can be reversed (i.e., thesuture enters the posterior leaflet from the atrial side). In one suchembodiment, the snare catheter can be inserted transfemorally into theleft ventricle while the delivery catheter can deliver the suture 36into the left atrium transseptally.

FIGS. 16A-16B shows an embodiment of another alternative method ofdelivering a suture or rail 36 into the heart, with the suture loop 36extending through the atrial septum into the left atrium, then betweenthe leaflets of the mitral valve into the left ventricle, and finallythrough the posterior leaflet 8 into the left atrium. The snare catheter40 can be inserted transseptally (FIG. 8A) into the left atrium tocapture the leading end of the suture 36 and bring it back outside thepatient's body, leaving behind a suture loop as shown in FIG. 16B forsubsequent device deployment. As discussed above, in some embodiments,the directionality of suture loop 36 delivery can be reversed (i.e., thesuture enters the posterior leaflet from the atrial side).

FIGS. 17A-17C show embodiments of exemplary suture loops for delivery ofa device to an anterior leaflet 6 of the mitral valve. FIG. 17A shows aloop 36 that extends into the left ventricle via the aortic valve, thenenters the left atrium between the leaflets of the mitral valve, thenextends through the anterior leaflet 6 into the left ventricle, andexits the heart via the aortic valve. FIG. 17B shows a suture loop 36that extends into the left ventricle via the aortic valve, then throughthe anterior leaflet 6 into the left atrium, and exits the left atriumtransseptally. FIG. 17C shows a loop that enters the left atriumtransseptally, extends through the anterior leaflet 6 into the leftventricle, then enters the left atrium between the leaflets of themitral valve, and finally exits the left atrium transseptally.

FIG. 19 shows an alternative embodiment of a prosthetic device,indicated generally at 600. The prosthetic device 600 provides increaseddownward force on the free end of leaflet 8. The prosthetic device 600includes a body 602 having a first end portion 604 and a second endportion 606. The body 602 can be positioned on the atrial surface of thenative leaflet as shown and can be secured thereto with a suture ortether 608. The suture 608 can be secured at a first end to the firstend portion 604 of the body 602, such as with a fastener 612 (aspreviously described), extends through the leaflet 8, and is secured atits opposite end to the second end portion 606 of the body.

The prosthetic device 600 further includes a stiffening member 610placed at the subannular surface of mitral valve 8, such as by mountingor coupling the stiffening member to the suture 608. The stiffeningmember can comprise a segment of wire, a polymer and/or Nitinol band, ora polymer and/or Nitinol tube. Other biocompatible material of suitablestiffness may also be used. Generally speaking, the stiffening member610 is relatively more stiff or rigid than the body 602 and the suture608. In the illustrated embodiment, the stiffening member 610 comprisesa tubular or cylindrical member (e.g., a polymer tube) that can becoaxially disposed around the suture 608. The stiffening member 610 canbe sized such that an upper end 614 can contact or is in close proximityto the subannular surface of the native valve 8 and can have a upwardlycurved lower portion 616 spaced from the free end of the leaflet 8.

The prosthetic device 600 can be implanted as described above inconnection with FIGS. 18A-18F, but with the stiffening member 610 beingthreaded on the suture 608 adjacent the second end portion 606 of thebody. Slack in the suture 608 in the suture may be adjusted (asdescribed above in connection with FIG. 18F) to produce or less force inthe ventricular direction. The downward force, in the ventriculardirection, increases the efficacy of the device by increasing theoverall stiffness the prosthetic device and the native leaflet, therebypromoting a better seal with the opposing native leaflet.

FIG. 20 shows comparison data before and after implantation of aprosthetic device 100 without a stiffening member and a prostheticdevice 600 with a stiffening member 610. Graph 700 show results forthree hearts with different degrees of mitral valve regurgitation,indicated at 710, 720, and 730. In the graph, “baseline” refers toregurgitation of the mitral valve without a prosthetic device, and “run”refers to regurgitation of the mitral valve in which either theprosthetic device 100 or the prosthetic device 600 has been implanted.As can be seen, in all three examples 710, 720, 730 use of thestiffening member further reduced regurgitation, with the mostsignificant improvement occurring in example 720.

FIGS. 21-31 show additional embodiments of a suture-rail deliveryassembly and methods to deploy a suture rail 800 through a nativeleaflet for subsequent implantation of a prosthetic device (e.g., aprosthetic device 100) on the native valve leaflet. The suture-raildelivery assembly in the illustrated embodiment generally comprises asteerable catheter 816, a crossing catheter 900, a needle wire 1000, anda snare catheter 1110.

FIG. 21 shows the suture rail 800 deployed within the heart. The suturerail 800 comprises a length of suture 802, for example 2-0 monofilamentpolyethylene, such as Deklene® II, or other suitable material or size.The suture 802 can extend from a suitable insertion point into thevasculature, such as the femoral vein, and extend to the heart 804. Inthe example shown in FIG. 21, the suture 802 extends from the peripheralvasculature through the inferior vena cava 806, into the right atrium808, through the interatrial septum 810, through the atrial side of theposterior leaflet 814 adjacent the annulus 812 (desirably at the P2position of the leaflet 814), around the free end of the leaflet 814 andthen back into the peripheral vasculature following the same path fromwhere it came, forming a loop extending through the leaflet 814.

The suture rail 800 may also originate in the high pressure vasculatureand advanced to the heart in a retrograde direction, for example fromthe femoral artery, or be inserted via the superior vena cava, forexample from the jugular vein. The suture 802 alternatively can extendthrough the annulus 812 (such as at a location adjacent the P2 positionof the native leaflet) rather than through the leaflet itself.

FIG. 22 shows an embodiment of the steerable catheter 816, which isconfigured to extend into the left ventricle and deliver the suture rail800 to an area below the posterior leaflet 814, as described in greaterdetail below. The steerable catheter 816 comprises a proximal endportion 818 and a distal end portion 820. The proximal end portion 818of the steerable catheter 816 can comprise a handle 822, from which ashaft 832 extends. Mounted on the shaft 832 adjacent the handle 822 isan entry port, such as in the form of a y-connector 824 that is incommunication with a side opening in the shaft and a respective lumen inthe shaft. The y-connector 824 can be used to allow insertion of othertools, for example a snare catheter 1100 or guide wire, into thesteerable catheter, as further described below.

The handle 822 can also comprise a plurality of other access ports, forexample, ports 826 and 828 extending from the proximal end of handle822. The access ports 826, 828 allow other tools or catheters to beinserted in lumens in the shaft 832. For example, as shown in FIG. 22,the crossing catheter 900 can be inserted into and through the steerablecatheter 816 via the access port 826 and the needle wire 1000 can beinserted into and through a respective lumen of the crossing catheter.The handle 822 of the steerable catheter 816 can further comprise anadjustment mechanism 830 configured to adjust the curvature of asteerable section 838 of the shaft 832, as further described below.

FIG. 24 shows a cross-sectional view of the shaft 832, according to oneembodiment. In the illustrated embodiment, the shaft 832 has fivelumens, including a first side lumen 852, a second side lumen 854, thirdand fourth side lumens 866, and a central lumen 862. The first sidelumen 852 (also referred to as a “snare-catheter lumen”) is sized andshaped to receive the snare catheter 1100 and two sections of the suture802. As shown, the snare-catheter lumen 852 can have an ovalcross-sectional shape (in a plane perpendicular to the length of theshaft 832) to better accommodate the snare catheter 1100 and the twosections of the suture 802. The snare-catheter lumen 852 has a proximalend in communication with the entry port 824 and a distal end incommunication with a side opening 834 formed in the distal end portionof the shaft 832 (FIG. 22).

The second side lumen 854 desirably extends the entire length of theshaft and has a proximal end in communication with the entry port 826and a distal end forming a distal opening at the distal end of the shaft832. Thus, as can be seen in FIGS. 22 and 24, the crossing catheter 900can be inserted into the entry port 826 and advanced through the lumen854, and the needle wire 1000 can be inserted into and advanced throughthe lumen of the crossing catheter 900. The lumen 854 can have an innerliner 856 that desirably extends the entire length of the shaft 832. Theinner liner 856 can comprise, for example, a braid reinforced polymerextrusion having one or more extruded layers. The reinforcing braid canbe a braided sleeve (e.g., a braided metal sleeve) extending coaxiallyover the one or more extruded layers. In one specific implementation,the inner liner 856 comprises a nylon 12 outer extrusion, a Pebax® innerextrusion, and a braided stainless steel sleeve extending over the outerextrusion, although other suitable materials can be used. The outersurface of the inner liner 856 can be fixedly secured to the innersurface of the lumen 854, such as with a suitable adhesive.

The central lumen 862 serves as a pull wire lumen that allows passage ofa pull wire 864. The third and fourth side lumens 866 can be open lumensor “dummy” lumens 866, which can extend along diametrically opposingsides of the central lumen 864. The lumens 866 can be potted, orotherwise sealed, to maintain hemostasis. Alternatively, one or bothlumens may be used to pass a guide wire or other tool into the shaft832. The lumens 866 can aid in providing uniform stiffness about thecentral axis of the shaft 832, which in turn provides for a smoothertorque response of the shaft when it is torqued while in a deflectedstate.

The pull wire 864 has a proximal end operatively connected to theadjustment mechanism 830 and a distal end fixed within the shaft 832 ata distal end 868 of the steerable section 838. The adjustment mechanism830 is configured to increase and decrease tension in the pull wire toadjust the curvature of the steerable section 838 of the shaft 838. Forexample, rotating the adjustment mechanism 830 in a first direction(e.g., clockwise) increases the tension in the pull wire, which causesthe steerable section 838 to bend or deflect into a curved configuration(as shown in FIG. 22). Rotating the adjustment mechanism in the oppositedirection (e.g., counter-clockwise) reduces tension in the pull wire,which allows the steerable section 838 to return to its non-deflectedconfiguration under its own resiliency. In the illustratedconfiguration, as shown in FIG. 22, the steerable section 838 can bend180 degrees to permit navigation around the posterior leaflet 814 andpositioning of the distal end 840 of the shaft 832 at the subannulargroove of the posterior leaflet 814, as further described below.

The steerable section 838 can be constructed from a relatively moreflexible material than the portion of the shaft proximal of thesteerable section or otherwise can be constructed to be relatively moreflexible than the portion of the shaft proximal to the steerablesection. In this manner, the curvature of the proximal portion canremain substantially unchanged when the curvature of the steerablesection is adjusted by application of tension from the pull wire.Further details of the construction of the handle and the adjustmentmechanism are described in U.S. Patent Application Publication Nos.2013/0030519, 2009/0281619, 2008/0065011, and 2007/0005131, which areincorporated herein by reference.

The steerable section 838 can comprise a slotted metal tube 842 (FIG.23) covered by a polymer sleeve or outer layer. As shown in FIG. 23, theslotted tube 842 in the illustrated configuration comprises a proximalend portion 844, a distal end portion 846, an intermediate portion 848extending between the proximal and distal end portions, and a pluralityof circumferentially extending, axially-spaced slots 850 formed in theintermediate portion 848, which impart flexibility to the steerablesection. The tube 842 can be made of Nitinol or another suitablebiocompatible metal with sufficient stiffness. The tube 842 can beformed, for example, by laser-cutting the slots 850 in a tubular pieceof metal. The distal end of the pull wire 864 can be affixed to thedistal end portion 846 of the tube, such as by welding. Except where thedistal end of the pull wire 864 is affixed to the distal end portion846, the pull wire can be “free-floating” within the much larger lumenof the tube 842, meaning that the pull wire can easily slide relative tothe inner surface of the lumen with minimal friction, thereby preventingor at least minimizing kinking of the pull wire.

A conventional steerable catheter has a pull wire located within a pullwire lumen that is offset to one side of the central longitudinal axisof the catheter. A drawback of this design is that the catheter suffersfrom a phenomenon known as “whipping” when it is torqued or rotatedrelative to its central longitudinal axis to adjust the rotationalposition of the distal end portion of the catheter while it is in acontoured configuration following the contour of the anatomical pathwaythrough which the catheter extends. When the catheter is rotated in thiscontoured configuration, the pull wire exerts uneven forces along thelength of the delivery device, which causes the delivery device tobecome unstable and spring back to its non-torqued, low energy state.

As noted above, the pull wire 864 extends through a centrally locatedlumen 862 that extends along the central longitudinal axis of the shaft832. Advantageously, placing the pull wire in a centrally located lumenprevents the so-called “whipping” phenomenon of the shaft when atorqueing force is applied to shaft, allowing for controlled 360-degreetorqueing of the shaft 832; that is, the distal end of the shaft can berotated relative to the central longitudinal axis to any positionthrough 360 degrees in three-dimensional space.

FIG. 25 shows details of the construction of a specific implementationof the shaft 832. In the illustrated configuration, the shaft 832comprises a first section 870, a second section 872, a third section874, and a fourth section 876. The fourth section 876 includes asteerable section 838 and a tip portion 878 distal to the steerablesection. The first section 870 can be connected to the handle 820 (notshown in FIG. 25). The first section 870 has a length L₁, which can varydepending on a patient's height or point of vascular access. The firstsection 870 can comprise a polymer extrusion formed from one or morelayers of different material. In a specific implementation, for example,the first section 870 comprises an inner layer made of nylon or ProPelland an outer layer made of 72D Pebax® or ProPell.

The second section 872 has a length L₂, which in certain embodiments canbe approximately 10-12 cm. The second section 872 can comprise a polymerextrusion formed from one or more layers of different material. In aspecific implementation, for example, the second section 872 comprisesan inner layer made of 72D Pebax® or ProPell and an outer layer made of72D Pebax® or ProPell.

The third section 874 has a length L₃, which in certain embodiments canbe approximately 8 cm. The third section 874 can comprise a polymerextrusion formed from one or more layers of different material. In aspecific implementation, for example, the third section 874 comprises aninner layer made of 55D Pebax® or ProPell and an outer layer made of 55DPebax® or ProPell.

The shaft 832 can further comprise a braided outer layer or sleeveextending over one or more of the first, second, and third sections 870,872, 874, respectively. In particular embodiments, the braided layerextends over the entire length of the first and second sections 870,872, and extends over the third section 874 from a first location wherethe third section is connected to the second section to a secondlocation just proximal to the opening 834. Thus, the third section 874can be subdivided into a braided section 876 and an unbraided section878. The braiding can comprise, for example, 304V stainless steel wire,with dimensions of approximately 1 mil by 5 mil. The braid can havesixteen carriers, with fifty-five picks per inch (PPI), in a standard1-over-2-under-2 pattern. In alternative embodiments, the braided layercan extend the entire length or substantially the entire length of theshaft 832.

The steerable section 838 can comprises a slotted metal tube 842 and anouter sleeve or jacket made of, for example, 32D Pebax® or ProPell. Inparticular embodiments, the steerable section 838 has a bend radius ofapproximately 10-14 mm, and can bend up to at least 180 degrees. Theouter jacket of the steerable section can be corrugated or ridged tofacilitate bending. When the steerable section 838 is fully deflectedsuch that the tip portion 878 extends substantially parallel to thethird section 874, the distance D₁ from the distal most location of thesteerable section 838 to the distal end 840 of the shaft can beapproximately 2 cm. The longitudinal spacing between the distal end 840of the shaft and the side opening 834 extends a distance D₂, which canapproximately 1 cm.

FIG. 26 shows a crossing catheter 900, according to one embodiment,which is configured to cross or extend through a native leaflet or theannulus 812 of the mitral valve for subsequent placement of the suture802. The crossing catheter 900 comprises an elongated shaft 902 that canhave a lumen extending along its length for receiving the needle wire1000. The crossing catheter 900 can further include a leur fitting 904connected to the proximal end of the shaft to facilitate insertion ofthe needle wire 1000 into the lumen of the shaft. The fitting 904 canalso be configured to lock or retain the needle wire in place relativeto the crossing catheter. The shaft 902 desirably has a pre-shaped orpre-curved distal end portion 906, which helps prevent or minimizekinking as it is advanced through the steerable section 838 of thesteerable catheter when the steerable section is placed in the curvedconfiguration.

In particular embodiments, the shaft 902 of the crossing catheter 900has an outside diameter of about 0.27 inch, an inner diameter (thediameter of the lumen) of about 0.18 inch, and an overall length ofabout 69 inches or greater. The shaft 902 can comprise a polymerextrusion of one or more layers and can have a braided sleeve or outerlayer extending over the extrusion. In one specific implementation,shaft 902 can comprise a multilayer extrusion comprising an inner layermade of ProPell, an intermediate layer made of nylon 12, and an outerlayer made of ProPell. In an alternative implementation, the extrusioncomprises a PTFE inner layer and the outer layer can contain bariumsulfate. The barium sulfate can provide contrast during fluoroscopy. Thebraided outer sleeve can be similar to the braiding described above inconnection with the shaft 832 of the steerable catheter, except that thecrossing catheter shaft 902 desirably is stiffer. Thus, for example, a 5mil by 25 mil 304V stainless steel wire can be used to form the braid.The braid PPI can be approximately 80-90. The distal end portion 906 canbe pre-curved to a diameter of about 1 inch.

FIG. 27 shows an example embodiment of a needle wire 1000 for puncturinga native leaflet or the annulus 812 of the mitral valve 814. The needlewire 1000 comprises a proximal portion 1002, a distal portion 1004, anda sharpened tip 1006 configured to puncture native tissue, such as theannulus 812 or a leaflet 814. The proximal portion 1002 can besubstantially straight in an un-deflected state and the distal portion1004 can be curved in an un-deflected state. The distal portion 1004 canbe, for example, shape-set or pre-curved to form a 360-degree curvehaving a diameter of, for example, about 19 mm. The overall length ofthe needle wire 1000 is preferably longer than the crossing catheter 900to allow for insertion and manipulation. In one specific implementation,the needle wire 1000 has a length greater than 75 inches, is made ofsolid Nitinol, and has an outside diameter of approximately 0.16 inch toallow for insertion through the crossing catheter 900.

FIGS. 28 and 29 show different embodiments of a snare catheter that canbe used for capturing an end of the suture 802 once it is passed throughthe native leaflet or the annulus 812. FIG. 28 shows an embodiment of asnare catheter 1100 comprising an elongated shaft 1102 and a snare loop1104 extending from the distal end of the shaft 1102. The snare loop1104 is radially expandable from a collapsed delivery state to anexpanded, functional state (shown in FIG. 28) for capturing the end ofthe suture 802. In the delivery state, opposite sides 1108 of the loop1104 are compressed toward each other such that the sides 1108 aregenerally straight and are in close proximity to each other such thatthe snare catheter 1100 can be advanced through the lumen 852 of thesteerable catheter 816. When the snare loop 1104 is advanced from thedistal opening 834 of the steerable catheter 816, the snare loop 1104can expand to its functional size for capturing the suture 802, asfurther described below.

The snare loop 1104 can extend from the shaft 1102 at an angle less than180 degrees, such as a 90-degree angle to facilitate placement of thesnare loop at a desired position inside the heart when capturing thesuture 802. The snare loop 1104 can be generally oval in shape and canhave a radially protruding section 1106 diametrically opposed to thelocation where the loop is attached to the shaft. The protruding section1106 helps the snare loop 1104 collapse from the expanded state to thedelivery state when the opposite sides 1108 of the loop are pressedtoward each other. In one specific implementation, the loop 1104 can beconstructed from an 8-mil shape-set Nitinol wire. The loop 1104 canalternatively be constructed from gold plated tungsten, or othersuitable materials that allow flexibility, shape memory, and/or contrastunder fluoroscopy.

FIG. 29 shows an alternate embodiment of a snare catheter 1150comprising an elongated shaft 1152 and a snare loop 1154 extending fromthe distal end of the shaft 1152. The snare loop 1154 can be shape-setsuch that it defines a distal protruding portion 1156 and a recessedportion 1158. In the expanded state of the loop (shown in FIG. 29), therecessed portion 1158 wraps or extends partially around an imaginaryline extending along the central longitudinal axis of the shaft 1152.The recessed portion 1158 can promote suture capturing inside the body.Shapes for the snare catheters 1100, 1150 are not limited to thosediscussed above and shown in the figures. Other shapes for the snareloops, such as multiple loops, baskets, and hexagonal or asymmetricalloops, can be used.

Feeding a flexible suture through a relatively long catheter can bedifficult. Because a suture is not ridged, advancing it through acatheter lumen can cause kinking at the insertion point, typically aleur fitting, and prevent deployment at the other end of the catheter.To prevent kinking, the suture 802 can be affixed to one end of a smalldiameter wire. The wire, which has much higher column strength than thesuture, can be used to pull the suture distally through the steerablecatheter 816. The wire can be, for example, a Nitinol wire having adiameter approximately the same as the diameter of the suture.

In certain embodiments, the distal end of the wire can be advancedthrough the crossing catheter 900 (which extends through the steerablecatheter 816) and captured by the snare catheter 1100 inside the heart.The distal end of the wire can be retrieved by the snare catheter andpulled into the steerable catheter 816 via the distal side opening 834.The wire, along with the suture 802, can be pulled proximally throughthe lumen 852 of the steerable catheter 816 until the distal end ofsuture 802 exits the steerable catheter via the opening in they-connector 824. Alternatively, a short length suture can be affixed tothe distal end of the wire to aid in capturing by the snare catheter1100.

In lieu of or in addition to the use of a thin wire to advance a suturethrough a suture through a catheter lumen, a suture-feeding device 1250(FIG. 30) can be used to advance a suture through a catheter lumen. Asshown in FIG. 30, the suture-feeding device 1250 in the illustratedembodiment comprises an inner stability tube 1252 and an outer feedingtube 1254, which can translate telescopingly along the inner stabilitytube 912 in the directions of double-headed arrow 1256. In use, thedistal end of the inner stability tube 1252 is coupled to the proximalend of a catheter shaft 1260. In the illustrated embodiment, forexample, the inner stability tube 1252 can be connected to a luerfitting 1258 disposed on the proximal end of the catheter shaft 1260.Alternatively, the distal end of the inner stability tube 1252 can beremovably affixed to the luer fitting 1258 with a tuohy borst adapter orcan be connected directly to the proximal end of the catheter shaft1260.

The inner diameter of the outer feeding tube 1254 can be slightly largerthan the outer diameter of the inner stability tube 1252. The innerdiameter of the stability tube 1252 is preferably slightly larger thanthe outer diameter of the suture 802.

In use, the outer feeding tube 1254 can be placed around inner stabilitytube 1252 and a suture 802 can be fed into the inner stability tube 912and into the catheter shaft 1260. The feeding tube 1254 is positionedsuch that a distal portion 1262 surrounds the inner stability tube 1252and a proximal portion 1264 surrounds a portion of the suture 802, asdepicted in FIG. 30. The proximal portion 1264 can be pinched, forexample, using fingers, a hemostat, or other suitable tool, such thatthe proximal portion is compressed against and engages the suture. Thefeeding tube 1254 is then advanced distally over the inner tube 1252,thereby pushing the suture 802 further into the catheter shaft 1260.After advancing the suture, the pinching force on the outer feeding tube1254 can be released and the feeding tube is retracted to the distalposition to repeat the process of engaging and advancing the suture 802through the catheter shaft 1260.

In one specific implementation, the suture-feeding device 1250 can beconnected to the crossing catheter 900 and used to advance a suturethrough the lumen of the crossing catheter shaft 902 into the heart.

FIGS. 31A-31J show cross-sections of a heart showing the implantation ofthe suture-rail 800 (for example, via a transseptal approach) throughthe posterior leaflet 814, using the suture-rail delivery assembly ofFIGS. 21-30, for subsequent introduction of a prosthetic device (e.g.,prosthetic device 100) into the heart.

FIG. 31A shows the delivery of a first, outer catheter 1200 in anantegrade direction into the right atrium (via the superior or inferiorvena cava), through the interatrial septum and into the left atrium. Asecond, intermediate catheter 1202 is advanced through the firstcatheter 1200 into the left atrium and directed downwardly to an areaabove the native mitral valve leaflets. The first catheter 1200 and/orthe second catheter 1202 can have steering mechanisms configured tocontrol the deflection of the catheters to assist in advancing thecatheters into the left atrium. Alternatively, the distal end portionsof the first catheter 1200 and/or the second catheter 1202 can bepre-curved to assume the curved shapes shown in FIG. 31A. The steerablecatheter 816 can then be advanced through the second catheter 1202 andthe native mitral valve leaflets until the steerable portion 838 isadvanced into the left ventricle downstream of the native valveleaflets.

Referring to FIG. 31B, the steerable portion 838 is then deflected andtorqued as needed to position the distal end 840 of the steerablecatheter 816 against the subannular groove of the native leaflet 814. Inthe example shown, the steerable portion 838 wraps around the posteriorleaflet 814 and does not extend deep into the ventricle. With the distalend 840 positioned against the subannular groove, the crossing catheter900 and the needle wire 100 can be advanced through the lumen 854 (FIG.24) of the steerable catheter 816. Alternatively, the crossing catheterand needle wire can be inserted into the steerable catheter beforedeflection and positioning of the distal end 840 of the steerablecatheter 816.

As shown in FIG. 31C, the crossing catheter 900 and the needle wire 1000are advanced in the distal direction until the crossing catheter and theneedle wire puncture and extend through the native leaflet 814 into theleft atrium. The crossing catheter and the needle wire can be lockedaxially relative to each other (e.g., at their proximal ends) with theneedle wire extending slightly beyond the distal end of the crossingcatheter to prevent relative movement between these two components inthe axial direction as they are advanced through the native leaflet. Asnoted above, the crossing catheter 900 and the needle wire 1000 can havecurved distal end portions that curve away from the atrium wall to avoidtrauma to adjacent tissue. The curvature of the crossing catheter 900also helps direct the suture 802 back toward the portion of thesteerable catheter 816 in the left atrium, as further described below.

Once the crossing catheter 900 is advanced through the native leaflet814, the needle wire 1000 can be unlocked from the crossing catheter andremoved from the body, leaving the crossing catheter in place within theheart, as shown in FIG. 31D.

Referring to FIG. 31E, the snare catheter 1100 can then be advancedthrough the lumen 852 (FIG. 24) of the steerable catheter until thesnare loop 1104 emerges from the distal side opening 834 into the leftatrium. The snare loop 1104 can be positioned around the distal endportion of the crossing catheter 900, as depicted in FIG. 31E. With thesnare loop 1104 positioned around crossing catheter 900 on the atrialside of the native leaflet 814, the suture 802 can be advanced throughthe crossing catheter 858 until it extends beyond the crossing catheterand through the snare loop 1104 in the left atrium, as shown in FIG.31F.

With the suture 802 extending through the snare loop 1104, the snarecatheter 1100 can be retracted back into the steerable catheter 816,drawing the suture 802 proximally into the distal side opening 834, asshown in FIG. 31G. The snare catheter 1100 can be fully retracted fromthe steerable catheter, drawing the suture 802 outwardly from the portof the y-connector 824 (FIG. 22). The suture 802 can thus extend fromoutside the body, through the inner lumen of the crossing catheter 900,though the native leaflet 814 and back through the snare lumen 852 ofthe steerable catheter 816 with both end portions of the suture residingoutside the body.

The crossing catheter 900 can then be retracted and removed from thesteerable catheter 816, leaving the suture 802 in place within theheart, as shown in FIG. 31H. The first catheter 1200 and the secondcatheter 1202 can be left in place within the left atrium for subsequentdelivery and implantation of a prosthetic device on the native leaflet.

FIGS. 32A-32D and 33A-33B illustrate another exemplary prosthetic device1300, which can be used to augment a heart valve leaflet to improvevalve coaptation and treat valve regurgitation. As described elsewhereherein, the device 1300 can be secured to and/or around a heart valveleaflet, such as a mitral valve leaflet, to add bulk to the leafletand/or extend the length of the leaflet, which can help the leaflet sealthe heart valve and prevent or reduce regurgitation of blood through thevalve. The device 1300 can be delivered and implanted usingtranscatheter techniques, as are described elsewhere herein, and canexpand from a crimped delivery configuration to a functionalconfiguration once positioned inside the heart.

The device 1300 includes a flexible, expandable body 1302, a first endportion 1304 coupled to one end of the body, and a second end portion1306 coupled to the other end of the body. The body 1302 can comprise agenerally tubular structure defining an internal lumen extending fromthe first end portion 1304 to the second end portion 1306. As usedherein, the term “tubular” means that the body has an annular crosssection (in a plane perpendicular to the length of the body) thatdefines a lumen and does not necessarily require the body to have a truecylindrical shape. Indeed, the body 1302 in the illustrated embodimenthas a wider intermediate portion that tapers in both directions towardthe opposite ends of the body.

FIG. 32A shows a delivery configuration wherein the device 1300 iscollapsed and has a minimal cross-sectional profile and can be containedwithin a delivery catheter. FIG. 32B shows a configuration wherein thebody 1302 is released from its delivery catheter and has expanded to alarger cross-sectional profile. FIG. 32C shows the device 1300 curled upwith the end portions 1304 and 1306 positioned adjacent to each other,which illustrates a configuration where the body 1302 is curled orwrapped around the free end of a leaflet with the end portions 1304 and1306 being positioned on opposite sides of the leaflet. In the positionof FIG. 32C, the end portions 1304 and 1306 can be secured to theleaflet, such as with one or more sutures or fasteners passing throughthe leaflet, to anchor the device 1300 to the leaflet. FIG. 32D showsthe device 1300 in an implanted configuration with the body 1302 beingfurther radially or laterally expanded, which allows the body to fill agap between the native leaflets and reduce regurgitation between thenative leaflets.

FIGS. 33A and 33B show two orthogonal side views of the device 1300,while FIG. 33C shows an end view. In its relaxed, natural state, thebody 1302 can have a generally elliptical or flattened circularcross-sectional profile with a wider major lateral dimension (verticaldimension in FIG. 33C) and a smaller minor lateral dimension (horizontaldimension in FIG. 33C). This flattened profile allows the body 1302 toreadily curl (see FIG. 32C) around a leaflet and lie with the flattenedinner surface against the leaflet and with the major lateral dimensionspread across the surface of the leaflet.

The device 1300 can include a passageway 1312 extending longitudinallythrough the body 1302 and through both end portions 1304 and 1306. Thepassageway 1312 allows the device 1300 to be advanced over a guide rail,such as a suture or cord, into the heart and around the target leaflet.As described elsewhere herein, a guide suture can be positioned throughthe leaflet before the device 1300 is delivered and the device 1300 canthen be advanced over the guide suture and positioned with the first endportion 1304 on one side of the leaflet (e.g., the atrial side) and thesecond end portion 1306 on the other side of the leaflet (e.g., theventricular side). The first end portion 1304 can include a lateralpassageway 1308 and/or the second end portion 1306 can include a lateralpassageway 1310, such that a guide suture or other guide rail can bepassed transversely through the end portion rather than longitudinallythrough the end portion. For example, in the configuration of FIG. 32C,a guide suture can pass transversely through the passageway 1308 infirst end portion 1304 and longitudinally through the passageway 1312 insecond end portion 1306 (see also FIG. 36).

The body 1302 can comprise a tubular braided mesh made of Nitinol orother resiliently deformable and/or shapesettable material that canregain a desired shape when released from the delivery catheter insidethe heart. The braided mesh also allows the body 1302 to expandlaterally when it is shortened longitudinally, and contract laterallywhen in its lengthened longitudinally. In the delivery configuration,the braided mesh can have an elongated, narrow profile without wrinklingor folding, allowing it to fit efficiently within a narrow deliverycatheter. When implanted around a leaflet, the braided mesh can have ashortened but laterally expanded profile. The braided mesh allows thebody 1302 to move between these different configurations withoutsubstantial stretching of the material, such as could occur with a solidsheet of elastic material instead of a braided mesh.

The body 1302 can also include an outer layer covering the inner braidedmesh to restrict or minimize blood flow through the body 1302. The outerlayer can also comprise a braided mesh, or can comprise a more solidsheet of material. For example, the outer layer can comprisepolyethylene terephthalate (PET), ultra-high-molecular-weightpolyethylene (UHMWPE), polytetrafluoroethylene (PTFE, ePTFE), urethane,etc. The outer layer can allow some degree of blood porosity, butdesirably restricts blood flow enough to prevent any substantial bloodflow through the device when the heart valve is closed. The underlyinginner braided mesh can serve more as a structural scaffold that is notnecessarily non-porous, while the outer layer can be less structurallysignificant and serve more to restrict blood flow.

FIGS. 46A and 46B show an exemplary prosthetic device 1500 that includesa body comprising an inner tubular braided mesh layer 1506 and an outertubular braided mesh layer 1504, along with end portions, or end caps,1508 and 1510 secured to the ends of the mesh layers. The inner braidedmesh 1506 can have larger openings between the strands of the mesh, andcan be comprised of thicker, stronger strands to provide structure,whereas the outer braided mesh 1504 can comprise finer strands andsmaller pores between the braided strands to restrict blood flow throughthe device. The outer braided mesh 1504 can extend the entire length ofthe body 1502 and be secured to the end portions 1508 and 1510 alongwith the inner braided mesh 1506. FIG. 46C illustrates the curledconfiguration of the device 1500 when a suture 1520 passing through theend portions 1508, 1510 is tensioned (as illustrated by arrows 1522,1524). The outer braided mesh 1504 can shorten in length along with thesuture 1520 and at the same time expand laterally without significantwrinkling or folding of the material, thereby enabling the outer surfaceto seal against the native tissue without undue blood leakage.

The end portions 1304, 1306 of the device 1300 can be more rigid thanthe body 1302 and can comprise various polymeric materials, such aspolyether ether ketone (PEEK), or metal material such as Nitinol.

FIGS. 34-41 illustrate an exemplary prosthetic device 1400 that issimilar to the device 1300 shown in FIGS. 32-33. The device 1400includes a body 1402, a first end portion, or end cap, 1404 and a secondend portion, or end cap, 1406. The body 1402 can have features similarto those describe for the body 1302 above.

The first end portion 1404 is secured to a tether 1408 that passesthrough a hole 1409 (FIG. 36) in the first end portion 1404. The tether1408 can be used to apply a proximal force on the device 1400, such asto retain the device within a delivery catheter, to retract the device1400 back into a delivery catheter, and/or to move the device proximallyafter being deployed.

The first end portion 1404 can have internal passageways as illustratedin FIGS. 38 and 40 that route the passage of a guide suture 1410 throughthe first end portion 1404 and through the device 1400. The guide suture1410 can be a previously implanted guide suture that extends through anative leaflet, as described in detailed above and shown in FIGS.31A-31H. As shown in FIGS. 35 and 36, the guide suture 1410 can form aloop that extends through the prosthetic device 1400 and the nativeleaflet. The guide suture 1410 includes a first portion 1411 thatextends outwardly from a proximally located delivery catheter 1420 (FIG.42), passes through a first lateral opening 1422 in the first endportion 1404 and extends into the inside of the body 1402. A secondportion 1412 of the guide suture 1410 extends through the body 1402 andthrough a longitudinal passageway in the second end portion 1406. Athird portion 1414 of the guide suture 1410 extends from the second endportion 1406, through the native leaflet 1418, into a second lateralopening 1424 in the first end portion 1404, and out through the firstlateral opening 1422. A fourth portion 1416 of the guide suture 1410extends from the first lateral opening 1422 back into the proximallylocated delivery catheter 1420 (see FIGS. 42-45 for an exemplarydelivery catheter). The proximal ends of the first portion 1411 and thefourth portion 1416 of the guide suture 1410 can be located outside ofthe patient's body.

As further shown in FIG. 38, the first end portion 1404 can also includea distal recess 1428 that receives and is secured to the proximal end ofthe body 1402. The recess 1428 communicates internally with the lateralopenings 1422 and 1424.

During delivery of the device 1400, the body 1402 can be substantiallystraight or slightly curved, as shown in FIGS. 34, 35, 37 and 38. Inthis configuration, the two strands of the guide suture 1410 passingthrough the first lateral opening 1422 curve around a sloped surface1423 (FIG. 38) of the first end portion and extend proximally, generallyparallel with the longitudinal direction of the device 1400. The slopedsurface 1423 provides a gradual curvature in the suture to minimize therisk of damaging the suture with a sharp right angled edge at the outletof the first lateral opening 1422. Similarly, the third portion 1414 ofthe guide suture that passes through the second lateral opening 1424 cancurve around a sloped surface 1425 that provides a gradual curvature inthe suture to minimize the risk of damaging the suture with a sharpright angled edge at the outlet of the second lateral opening 1424.

When tension is applied to the guide suture 1410, such as by pullingproximally on one or both of first and fourth portions 1411, 1416,respectively, of the guide suture, the body 1402 begins to curl aroundthe leaflet into the implanted configuration shown in FIGS. 36, 40, and41. As length of the guide suture is taken out of the prosthetic device(causing the circumference of the loop extending through the body 1402and the leaflet to decrease), the body 1402 curls up gradually. Thedistal end of the delivery catheter 1420 (see FIGS. 35 and 39) can bepositioned against the first end portion 1404 to hold the first endportion in place against one side of the leaflet while the loop isdecreased and the second end portion 1406 curls around against theopposite side of the leaflet (FIG. 41).

As shown in FIG. 40, when the body 1402 is curled into the deployedconfiguration, the second end portion 1406 can be oriented transverse tothe first end portion 1404. In this configuration the portion 1414 ofthe guide suture can extend transversely through the two lateralopenings 1422, 1424 of the first end portion, and can extend laterallyfrom the first end portion into the delivery catheter along the otherend of the guide suture 1410 and the tether 1408. As can be seencomparing FIGS. 38 and 40, the first end portion 1404 can rotate up toabout 90° relative to the delivery catheter during the deployment of thedevice 1400.

FIG. 41 shows the device 1400 curled around a mitral leaflet 1406 duringimplantation, with the end portions 1404 and 1406 on opposite sides ofthe leaflet. In this position, the guide suture 1410 can be pulledand/or relaxed to cause the body 1402 to become tighter or looser aroundthe leaflet and more or less bulky. For example, the guide suture can betightened until the body 1402 expands far enough to contact and sealagainst the opposing leaflet 1419. The process can be facilitated byusing imaging technology such as echocardiography and fluoroscopy tovisualize the size and positioning of the device 1400, the nativeanatomy, and blood flow. For example, the body 1402 can be expandeduntil no substantial regurgitation is observed through the subject heartvalve. The device 1400 can then be secured in that configuration bysecuring the guide suture, such as with a suture clip, suture lock,and/or knots, as described above.

FIGS. 42-45 show an exemplary delivery catheter 1420 that can be used todeliver and implant the device 1400 or similar devices. The catheter1420 includes a central lumen through which the two strands of the guidesuture 1410 pass and at least two outer side lumens 1430 spaced radiallyoutward from the central lumen through which the two strands of thetether 1408 pass. The catheter 1420 can further include two additionalouter side lumens 1431 to aid in providing uniform stiffness around thecentral longitudinal axis of the catheter. The outer lumens 1431 can be“dummy lumens” or can be used to pass instruments or other devicesthrough the catheter into the patient's body. The delivery catheter 1420includes a distal recess 1436 and distal outer rim 1438 that contact orare adjacent to the proximal end of the first end portion 1404 of thedevice 1400 during delivery into the heart.

Both the prosthetic device 1400 and the delivery catheter 1420 can behoused inside an outer catheter (not shown) during transvasculardelivery into the heart (e.g., in the manner that outer catheter 50 isused to house inner catheter 52 and prosthetic device 100 in FIGS. 3A-3Hduring delivery of prosthetic device). Alternatively, the prostheticdevice 1400 and the delivery catheter 1420 can be advanced through anouter catheter pre-inserted into the body such that a distal end of theouter catheter is positioned in the heart.

As shown in FIG. 44, the delivery catheter 1420 can include at least onesuture clip (or suture lock) 1440 positioned in the recess 1436 at thedistal end of the catheter 1420. The suture clip 1440 can be generallydisk shaped and can have one or more resiliently deformable flaps 1443that can be deflected to open a passage 1441 that allows the strands ofthe guide suture 1410 to pass through the suture clip between thecentral lumen 1432 and the device 1400. The suture clip 1440 ispositioned against an annular retainer 1442 that includes a projection1444 that projects distally through the suture clip and holds the flapof the suture clip open during delivery to allow the guide suture toslide through the suture clip with minimal resistance duringimplantation. The annular retainer 1442 includes a central passage 1446.

The delivery catheter 1420 also includes a tubular pusher 1434 (FIG. 43,44) that surrounds and/or defines the central lumen 1432 and is slidablelongitudinally relative to the retainer 1442 and suture clip 1440. Whenthe device 1400 is desirably positioned and the guide suture isdesirable tensioned, the pusher 1434 can be advanced distally throughthe passage 1446 in the retainer 1442 to contact and push the sutureclip 1440 distally apart from the retainer 1442, such that theprojection 1444 comes out of the suture clip and the flap(s) 1443 of thesuture clip can resiliently close against and engage onto the guidesuture 1410. When released from the retainer 1442 and secured onto theguide suture 1410, the suture clip 1440 can exit out of the distal endof the recess 1436 of the delivery catheter 1420 as the deliverycatheter is retracted proximally away from the implanted device 1400,leaving the suture clip 1440 engaged onto the two guide suture strandsagainst the side of the first end portion 1404 of the prosthetic device1400 adjacent the first lateral opening 1422 (see FIG. 40). FIG. 45Bshows the delivery catheter 1420 after the pusher 1434 has moveddistally and pushed out the suture clip 1440.

In FIGS. 44, 45A, and 45B, the pusher 1434 is shown extending only ashort distance longitudinally from the distal end of the catheter 1420.In some embodiments, the pusher 1434 is attached to the inside of a wirecoil 1450 of the catheter and the coil along with a coil cover layer1460 can be moved longitudinally relative to the outer portions of thecatheter to move the pusher 1434. The outer portions of the catheter1420 can include an outer annular body or shaft 1454 defining the outerlumens 1430, 1431, one or more layers of material 1462, 1464 lining theinside of the outer shaft, and a distal outer body or tip portion 1448that contains the retainer 1442 and the suture clip 1440. The innerlayers 1462, 1464 can comprise an extruded polymeric layer or braidedlayer, such as described above in connection with the catheter 816 ofFIGS. 22-25.

In alternative embodiments, the first end portion 1404 of the prostheticdevice 1400 can include a suture locking mechanism that can engage theguide suture. This can eliminate the need to apply a suture clip fromthe delivery catheter or otherwise secure the guide suture, or can beused in addition to the application of a suture clip. A suture lockingdevice can be located inside of or along the surface of the first endportion 1404 such that both strands of the suture 1410 pass through thesuture locking mechanism. The suture locking mechanism can comprise aone-way restrictor that allows the suture strands to be pull proximallythrough the first end portion to tighten the suture within the body1402, but prevents the suture strands from slipping back through thefirst end portion after implantation. In some embodiments, the suturelocking mechanism can include a ratcheting mechanism. In someembodiments, the suture locking mechanism can be selectively releasableto allow a user to add slack back into the guide suture and thenre-secure the locking mechanism.

FIGS. 47-49 illustrate devices that can be used to unwind and/orstraighten two strands of a suture or other cord (e.g., the guide suture1410) extending into a patient's vasculature. FIG. 49A illustrates asituation where a suture 1620 is looped at the left end and has twostrands extending to the right. The looped end can represent a portionof a guide suture 802 or a guide suture 1410 that extends through anative leaflet (as depicted in FIG. 21 or FIG. 35, for example). In FIG.49A, the two strands of the suture are twisted, which can inhibit thedelivery of a device over the suture strands. The suture strands canbecome twisted in various ways, both inside the vasculature of a patientand outside of the patient.

FIGS. 47 and 48 show two exemplary devices 1600 and 1610 that can bepassed over the twisted strands of the suture 1620 to untwist andstraighten them. The device 1600 includes a solid outer body or shaft1602, a single central lumen 1604 sized to accommodate both strands ofthe suture 1620, and two radially positioned lumens 1606 that create aweak spot along the length of the body 1602 to allow the body to bepeeled apart into two halves, as shown in FIG. 49C. The device 1610includes a solid outer body or shaft 1612, two separate inner lumens1614 for each suture strand, and two outer lumens 1616 that similarlycreate a weak spot along the length of the body 1612 to allow the bodyto be peeled apart into two halves. The body 1602, 1612 can comprise anysufficiently torqueable and bendable material, such as an extrudedpolymeric material.

Using the device 1600 as an example (the device 1610 can equally be usedin the same way), the free ends of the two suture strands can beinserted into the central lumen 1604 or into the two central lumens 1614(as shown in FIG. 49A), and then the device 1600 can be advanced overthe two suture strands (as shown in FIG. 49B) to untwist them. Theuntwisting of the suture strands can include rotation of the device 1600such that the loop at the distal end of the suture can remain fixed andnot need to rotate. The loop in the suture can extend through a leafletor other tissue/object and be prevented from rotating to untwist thesuture.

The free ends 1622 (FIG. 49C) of the suture strands can extend out ofthe proximal end of the device 1600 in the position shown in FIG. 49B,such that another catheter (e.g., containing the prosthetic device 1400and delivery catheter 1420) can be advanced over one or both of thesuture strands while the device 1600 is still on the suture strands.This other catheter can block the device 1600 from being pulled backproximally off of the suture strands as the other catheter is advanceddistally. To remove the device 1600, the body 1602 can be peeled apartinto two halves 1602A, 1602B (not necessarily equal is size) along theweak spots provided by the outer lumens 1606 (as shown in FIG. 49C). Thepeeling or tearing apart can occur outside of the patient's body. As thetwo halves 1602A, 1602B are peeled apart, the device 1600 can be pulledproximally over the suture strands out of the body until the entiredevice 1600 is out of the body and split into two parts that are removedfrom the suture strands and discarded, leaving the suture strandsuntwisted for the other catheter to be advanced over. The other cathetercan be advanced over the suture strands at the same time as the device1600 is being retracted and peeled apart, thereby preventing the suturestrands from becoming twisted again.

FIG. 50 shows a prosthetic device 1700 for treating valve regurgitation,according to another embodiment. The prosthetic device 1700 can have anoverall construction similar to the prosthetic device 1300 of FIGS.32-33 and therefore can have an elongated body 1702 and first and secondopposing end portions, or end caps, 1704,1706, respectively at oppositeends of the body. One or both of the first and second end portions 1704,1706 can have one or more barbs 1708 that can provide enhancedfrictional engagement with the native leaflet. In the illustratedembodiment, each of the first and second end portions 1704, 1706 has aplurality of barbs 1708. The barbs 1708 desirably have pointed ends thatcan penetrate the surface of the native leaflet to promote engagement ofthe end portions with the native leaflets.

FIG. 51 shows the prosthetic device 1700 implanted on a native leaflet.As shown, the barbs 1708 on the first end portion 1704 can engage andoptionally penetrate the atrial surface of the native leaflet while thebarbs on the 1708 on the second end portion 1706 can engage andoptionally penetrate the ventricular surface of the native leaflet (thebarbs are shown slightly spaced from the native leaflet for purposes ofillustration). The prosthetic device 1700 can be further secured inplace against the native leaflet with a suture and a fastener asdescribed in detail above.

FIG. 52 shows a modification of the prosthetic device 1700 in which thesecond end portion 1706 includes one or more barbs 1708 and the firstend 1704 includes one or more correspondingly shaped recesses 1710shaped to receive tissue of the native leaflet. When implanted around anative leaflet, the barbs 1708 press tissue of the native leaflet intothe recesses 1710 to promote anchoring of the prosthetic device. Incertain embodiments, the barbs 1708 can be configured to penetratecompletely through the native leaflet and extend into the recesses 1710.

In alternative embodiments, the first end portion 1704 can have one ormore barbs 1708 and the second end portion 1706 can have one or morerecesses 1710. Moreover, any of the embodiments disclosed herein caninclude one or more barbs on one or both ends of the prosthetic device,or one or more barbs on one end and one or more recesses on the otherend.

FIGS. 53-54 shows a prosthetic device 1800, according to anotherembodiment, comprising an elongated body 1802 and first and secondopposing end portions 1804,1806, respectively at opposite ends of thebody. One or both of the first and second end portions 1804, 1806 canhave one or more barbs 1808 that can provide enhanced frictionalengagement with the native leaflet. As shown in the end view of theprosthetic device of FIG. 53, the end portion 1804, 1806 can have aflattened configuration so as to be able to lay flat against thesurfaces of a native leaflet and therefore provide enhanced stability ofthe prosthetic device.

FIGS. 55A-55E illustrate a method for implanting a prosthetic heartvalve in the mitral position using a prosthetic device mounted on one ofthe native leaflets as a support structure for the prosthetic valve.FIG. 55A shows a rail 802 implanted through the posterior leaflet 8 aspreviously described in detail above. FIG. 55B shows a first prostheticdevice 100 partially deployed around the leaflet 8, which can bedelivered to the native leaflet as previously described. The firstprosthetic device 100 carries a second prosthetic device in form of aradially expandable support ring 1800. The first prosthetic device 100in the illustrated embodiment can extend or loop through the supportring 1800 such that the two components are linked together similar tolinks of a chain. The support ring 1800 can comprise, for example, anannular stent formed from interconnected struts or can comprise abraided structure.

As shown in FIG. 55B, the support ring 1800 is positioned between thenative leaflets and receives a transcatheter prosthetic heart valve1804. The prosthetic heart valve 1804 can be mounted on a deliverycatheter 1806, which can be advanced over a guidewire 1808. As shown inFIG. 55C, the first prosthetic device 100 can be fully deployed aroundthe native leaflet and secured in place, and the prosthetic heart valve1804 can be radially expanded against the inner surface of the supportring 1800. The prosthetic heart valve 1804 can be held in place by thefrictional engagement between the prosthetic valve and the support ring.The outer surface of the support ring 1800 have a plurality of barbs ortissue engagement members 1802 that can engage the anterior leaflet 6and/or other surrounding tissue to help anchor the support ring 1800 inplace between the two native leaflets. FIGS. 55D and 55E and side andtop views, respectively, showing the prosthetic valve 1804 expanded andheld in place within the support ring 1802 with all delivery devicesretracted from the heart. As shown in FIG. 55E, the prosthetic valve canhave prosthetic leaflets 1810 that regulate the flow of blood throughthe prosthetic valve.

The prosthetic heart valve 1804 can be a self-expandable prostheticvalve or a plastically-expandable heart valve, as known in the art. Aself-expandable heart valve can have a self-expandable frame made of ashape-memory material (e.g., Nitinol) that can radially expand to itsfunctional size when released from a delivery sheath, as known in theart. A plastically-expandable heart valve can have a frame made of aductile or plastically-expandable material (e.g., stainless steel orcobalt chromium alloy) that can be expanded to its functional size by aballoon or other expansion device, as known in the art. Examples of suchprosthetic heart valves that can be used in the disclosed method andassembly are disclosed in U.S. Patent Application Publication Nos.2012/0123529 and 2012/0239142, which are incorporated herein byreference.

FIGS. 56A-56E show a method for implanting a prosthetic heart valve inthe mitral position using multiple prosthetic devices mounted on thenative leaflets as support structure for the prosthetic valve. In thismethod, a first rail 802 a is implanted through the posterior leaflet 8and a second rail 802 b is implanted through the anterior leaflet 6, asshown in FIG. 56B. A first prosthetic device 1900 a is implanted aroundthe posterior leaflet 8 via the first rail 802 a, and a secondprosthetic device 1900 b is implanted around the anterior leaflet 6 viathe second rail 802 b, as shown in FIG. 56B. Each of prosthetic devices1900 a, 1900 b can be an expandable braided structure, such as describedabove and shown in FIGS. 32-33 and 46.

As shown in FIG. 56C, a prosthetic heart valve 1902 can be delivered toa position between prosthetic devices 1900 a, 1900 b via a deliverycatheter 1904 that can be advanced over a guidewire 1906. The prostheticheart valve 1902 can then be radially expanded to its functional sizeand held in place against the prosthetic devices 1900 a, 1900 b, asshown in FIGS. 56D and 56E. As shown in FIG. 56E, each of the prostheticdevices 1900 a, 1900 b can be sized and shaped to circumscribe abouthalf of the outer surface of the prosthetic valve 1902 (about 180degrees) such that collectively, the prosthetic devices 1900 a, 1900 bextend all the way around, or substantially all the way around theprosthetic valve. In other embodiments, more than two prosthetic devicescan be implanted on the native leaflets for use as support structure forthe prosthetic valve. For example, two or three such prosthetic devicescan be implanted on one or both native leaflets for use as supportstructure. In another embodiment, a single prosthetic device can bridgeor extend across one of the commissures of the mitral valve such thatthe single prosthetic device is implanted at least partially on bothnative leaflets.

FIGS. 57A-57D show the use of a rail 802 alone as a support structurefor a prosthetic heart valve. In the embodiment shown, the rail 802 isimplanted through the posterior leaflet 8. For this application, therail 802 desirably comprises a relatively stiffer material, such as ametal wire. As shown in FIGS. 57B-57C, a prosthetic heart valve 2000 isdeployed between the native leaflets 6, 8 but bears against the rail 802to help secure the prosthetic valve in place. The prosthetic valve 2002can have a plurality of barbs or tissue engaging members 2002 that canengage the anterior leaflet or other to enhance frictional engagement ofthe prosthetic valve with native tissue. In alternative embodiments, aseparate rail can be implanted through the anterior leaflet 6, ormultiple rails can be implanted through one or both leaflets for use assupport structure for a prosthetic valve.

FIGS. 58A-58E show another embodiment of a method for implanting aprosthetic heart valve in the mitral position using a prosthetic devicemounted on one of the native leaflets as a support structure for theprosthetic valve. In this embodiment, a rail 802 is implanted through aposterior leaflet 8, and a prosthetic support device 2100 is implantedon the posterior leaflet via the rail as previously described. Thesupport device 2100 can be an expandable braided structure, such asdescribed above and shown in FIGS. 32-33 and 46.

The support device 2100 can have barbs or tissue engaging members 2102to enhance frictional engagement of the support device with adjacenttissue. The support device 2100 can further comprise a lumen thatextends through the braided body of the support device in a directionfrom the left atrium towards the left ventricle. The lumen is sized toreceive a prosthetic heart valve 2104, which can be expanded to itsfunctional size within the lumen, as shown in FIGS. 58D and 58E.

FIG. 59 shows a prosthetic device 2200 for treating valve regurgitation,according to another embodiment. The prosthetic device 2200 can have anoverall construction similar to the prosthetic device 1300 of FIGS.32-33 and therefore can have an elongated body 2202 and first and secondopposing end portions, or end caps, 2204, 2206, respectively at oppositeends of the body. One or both of the first and second end portions 2204,2206 can have one or more barbs 2208 that can provide enhancedfrictional engagement with the native leaflet. In the illustratedembodiment, each of the first and second end portions 2204, 2206 has aplurality of barbs 2208, with the barbs of the first end portion beingoffset from the barbs of the second end portion. In this way, the barbsof one end portion can mesh or nest within the barbs of the other endportion with a native leaflet therebetween.

The prosthetic device 2200 further includes a biasing member 2210 thatis configured to move and retain the prosthetic device 2200 to a curledconfiguration around a native leaflet 8. In the illustrated embodiment,the biasing member 2210 extends through the body 2202 and has a firstend secured to the first end portion 2204 and a second end secured tothe second end portion 2206. The biasing member 2210 can comprise, forexample, a leaf spring or resilient piece of metal or wire that isbiased toward the curled configuration shown in FIG. 59. The biasingmember 2210 can be made of Nitinol, stainless steel, or other flexibleand resilient materials.

The biasing force applied by the biasing member 2210 on the end portions2204, 2206 of the prosthetic device causes the end portions to bearagainst the tissue of the native leaflet and clamp the native leaflettherebetween. In particular embodiments, the biasing force of thebiasing member 2210 is sufficient to retain the prosthetic device on thenative leaflet without an additional securing mechanism extendingthrough the leaflet (e.g., such as a suture). Thus, in such embodiments,the prosthetic device 2200 can be delivered and implanted on a nativeleaflet without the use of rail extending through the leaflet.Alternatively, the prosthetic device can be delivered to the nativeleaflet along a rail, which can then be completely removed from the bodyand not used to help secure the prosthetic device in place.

FIGS. 60-62 show another exemplary docking assembly, indicated generallyat 2300, for securing a prosthetic heart valve 2302 comprising a frame2304 and prosthetic leaflets 2306 as previously described herein in themitral position for treatment of mitral regurgitation, using inflatabledevices mounted adjacent to one of the native leaflets as a supportstructure for the prosthetic heart valve.

FIG. 60 provides a superior view of the mitral valve and the assembly2300, which can be comprised of two expandable or inflatable bodies 2310and 2320 that function as anchors for the prosthetic valve 2302. Inparticular embodiments, the bodies 2310, 2320 can each comprise apolyurethane balloon within an outer textile or fabric jacket comprisedof PET (polyethylene terephthalate), or other appropriate polymericmaterials or other suitable materials. The inflatable bodies 2310, 2320can be secured via sutures 2314, 2324 to the anterolateral commissure 9and posteromedial commissure 7 (which are enlarged for illustrativepurposes). These bodies can be configured and positioned to pivotallyengage a prosthetic heart valve 2302 and/or the commissures 7, 9, asfurther described below.

As shown in the perspective view of FIG. 61A, the bodies 2310, 2320 canhave a wedge-shaped or triangular cross-sectional profile in a planeperpendicular to the mitral valve defining narrower first, outer endportions 2312, 2322, respectively, that are secured via the sutures2314, 2324 to the anterolateral commissure 9 and posteromedialcommissure 7. Portions of the native posterior mitral valve leaflet 8are removed in this figure for illustration purposes to show thestructure of the present assembly. While they are shown as beingconnected via sutures, the bodies can be secured to the native tissue byvarious other appropriate techniques or mechanisms, such as barbedanchors, and/or microanchors. The portion of the bodies extending awayfrom the first end portions flare or increase in width as they extend totheir second, inner end portions, 2316, 2326, which can be positioned topivotally engage the prosthetic heart valve 2302.

In this manner, the bodies 2310, 2320 can pivot in response to changesin the pressure gradient across the mitral valve and enhance thegripping force against the prosthetic heart valve 2302. In someembodiments, one or both bodies 2310, 2320 may be pivotally connectedvia sutures 2318, 2328 or other appropriate techniques or mechanisms(e.g., mechanical couplers or fasteners, such as rings or links) on oneside of their inner ends 2316, 2326 to the prosthetic heart valve 2302.For example, the sutures 2318, 2328 (or other coupling mechanisms) canform loops that extend around the struts of the frame of the prostheticvalve and through the bodies 2310, 2320. The sutures 2318, 2328 can bepre-placed on the bodies 2310, 2320 and/or the prosthetic valve 2302 andthen tightened once implanted. Applying either suture 2318 and/or suture2328 allows the prosthetic heart valve 2302 to pivot relative to therespective body 2310 and/or 2320 to which it is attached, as shown inFIG. 61B.

In alternative embodiments, a docking assembly can include more than twoanchoring bodies 2310, 2320 and/or anchoring bodies 2310, 2320positioned at other locations on or adjacent the mitral valve annulus.For example, in one implantation, one or more anchoring bodies can beimplanted along the annulus or native leaflets between the commissures,such as at the A2 and P2 positions. In another implementation, theanchoring bodies 2310, 2320 can be implanted only at locations betweenthe commissures.

FIG. 62 shows an alternate embodiment of a docking assembly, indicatedgenerally at 2400, for securing a prosthetic heart valve 2402 in anative heart valve. The assembly 2400 can comprise inflatable and/orexpandable anchoring bodies 2410. The bodies 2410 can have the sameconstruction as the bodies 2310, 2320 of FIGS. 60-61, except that thebodies 2410 can have a different cross-sectional profile. In particular,the bodies 2410 can have a trapezoidal cross-sectional profile in aplane perpendicular to the native mitral valve. Each body 2410 in theillustrated embodiment can have a narrower first, outer end portion 2412defining a first surface that can be approximately half the width of,and extend parallel to a second surface located at a broader second endportion 2416 of the body. Between these surfaces, on the ventricularside of the body is a third surface 2415 that is perpendicular to thefirst two surfaces. Finally, opposite the ventricular surface is afourth, atrial surface 2417 that is neither parallel to norperpendicular from the first three surfaces, resulting in these foursurfaces forming a generally trapezoidal shape (in two dimensions).

Each body 2410 can be pivotably connected to an adjacent commissureand/or to the frame 2404 of the prosthetic valve 2402 implanted betweenthe bodies. For example, in some embodiments, the narrower first endportion may be secured via a suture 2414 to the appropriate commissure,as described above in connection with the bodies 2310, 2320. Thistrapezoidal shape still allows the body to pivot relative to theadjacent commissure and a prosthetic heart valve 2402. Additionally,each body 2410 can be pivotally connected to the frame 2404 of theprosthetic heart valve 2402 via a suture 2418, a mechanical connector(e.g., a ring or link) or another suitable connector. Each body 2410 canbe connected to the prosthetic heart valve at a location adjacent thebody's inner edge and its ventricular edge, as shown in FIG. 62.

In alternative embodiments, a docking assembly can comprise one or moreof the bodies 2410 of FIG. 62 and one or more of the bodies 2310, 2320of FIGS. 60-61B.

FIGS. 63-64 show another exemplary docking assembly, indicated generallyat 2500 for securing a prosthetic heart valve 2502 comprising a frame2504 and prosthetic leaflets 2506 as previously described herein in themitral position for treatment of mitral regurgitation, again usingexpandable or inflated devices mounted adjacent to one of the nativeleaflets as a support structure for the prosthetic heart valve.

FIG. 63 provides a superior view of the mitral valve and the assembly2500, which can be comprised of two expandable or inflatable bodies 2510and 2520 that function as anchors for the prosthetic heart valve 2502.In particular embodiments, the bodies 2510, 2520 can each comprise apolyurethane balloon with an outer textile or fabric jacket comprised ofPET (polyethylene terephthalate), or other appropriate polymericmaterials or other suitable materials. These bodies can be secured viasutures 2514, 2524 to the anterolateral commissure 9 and posteromedialcommissure 7 (which are enlarged for illustrative purposes). Thesebodies 2510, 2520 can be configured and positioned to secure and/or topartially surround the frame 2504 of the prosthetic heart valve 2502, asfurther described below.

As shown in the perspective view of FIG. 64, bodies 2510, 2520 can havea bracket-shaped cross-sectional profile in a plane perpendicular to thenative mitral valve defining first end portions 2512, 2522,respectively, that are secured via the sutures 2514, 2524 to theanterolateral commissure 9 and posteromedial commissure 7. Portions ofthe native posterior mitral valve leaflet 8 are removed for illustrationpurposes in this figure to show the structure of the present assembly.While they are shown as being connected via sutures, the bodies 2510,2520 can be secured to the native tissue by various other appropriatemeans, such as barbed anchors, and/or microanchors. The portion of thebodies extending away from the first end portions are of consistentheight as they extend to their second, inner end portions, 2516, 2526,which can be positioned to engage the frame 2504 of the prosthetic heartvalve 2502 and to secure the prosthetic heart valve 2502 in positionbetween the native leaflets 6, 8. Recesses can be formed on the innerend portions 2516, 2526 of the bodies of appropriate height to allow theprosthetic heart valve 2502 to be partially surrounded by the bodies2510, 2520. The inner end portions can form lower lips or flanges 2528and upper lips or flanges 2530. The lower and upper flanges 2528, 2530can extend radially inward of the frame 2504 to further secure theprosthetic valve relative to the bodies.

In particular embodiments, inflatable bodies 2510, 2520 cam be inflatedwith an injectable curable polymer, such as polymethyl methacrylate(PMMA), which can cure against the frame 2504 of prosthetic heart valve2502. In these embodiments, prosthetic heart valve 2502 can be deployedwhile the curable polymer is still soft, so that the inflatable bodies2510, 2520 can be “molded” to the outside of the frame 2504 ofprosthetic heart valve 2502, and can interdigitate with open cellslocated on the outside of the frame 2504 of the prosthetic heart valve2502, providing a secure docking for prosthetic heart valve 2502 withinthe docking assembly 2500.

The bodies 2310, 2320, 2410, 2510, and 2520 shown in FIGS. 60-64 can bedelivered to the native valve via a delivery catheter in a non-inflated,delivery configuration, and then inflated with an appropriate inflationmaterial once implanted inside the body. In some embodiments, the bodies2310, 2320, 2410, 2510, and 2520 can be inflated with an inflationfluid, such as saline, with a catheter coupled to a source of the fluidlocated outside the body. In other embodiments, the bodies 2310, 2320,2410, 2510, and 2520 can be inflated with a curable liquid (e.g., acurable polymer, such as polymethyl methacrylate (PMMA) or a curablebiocompatible adhesive) that is introduced in a liquid state into thebodies and cures or hardens to a solid or semi-solid state inside theheart. Devices for introducing an inflation fluid or curable liquid intoan implant within a patient's body are further described in U.S. Pat.No. 7,276,078, which is incorporated herein by reference.

In other embodiments, the bodies 2310, 2320, 2410, 2510, and 2520 can beformed from an expandable material, such as elastomeric material (e.g.,silicone rubber) or sponge-like material, that allows the bodies to becompressed to a smaller diameter or profile for delivery and toself-expand when released from the delivery catheter. In still otherembodiments, the bodies 2310, 2320, 2410, 2510, and 2520 can have asingle-layer or multi-layer construction that is self-expandable orexpandable via tethers or other means, such as described above inconnection with implants 1300, 1400, 1500, 1700, 1800, 1900, 2000, 2100,and 2200.

FIG. 65 shows another exemplary docking assembly, indicated generally at2600 for docking a prosthetic heart valve 2602 comprising a frame 2604and prosthetic leaflets 2606, as previously described herein, using abraided structure secured in multiple locations around the annulus assupport structure for the prosthetic valve. FIG. 65 is a top plan viewof the assembly 2600, taken from a superior view of the mitral valve.The assembly 2600 can be comprised of a braided structure 2610 having acentral ring or hub 2612 and a plurality of tubular arms or projections2614, 2616, 2618, and 2619 angularly spaced around and extendingradially outwardly from the hub 2612. The arms 2614, 2616, 2618, 2619can have a construction such as described above in connection withimplant 1300 shown in FIGS. 32-33 and 46. The hub 2612 can be sized tocompletely surround and seal against the outer surface of the prostheticvalve 2602.

In the illustrated embodiment, a first arm 2614 extends toward theposteromedial commissure 7 and can be attached thereto via a firstsuture 2624. A second arm 2616 extends toward the native posteriormitral valve leaflet 8 and can be attached thereto via a second suture2626 (e.g., at the P2 position). A third arm 2618 extends toward theanterolateral commissure 9, and can be attached thereto via a thirdsuture 2628. Finally, a fourth arm 2619 extends toward native anteriormitral valve leaflet 6, and can be attached thereto via a fourth suture2629 (e.g., at the A2 position). While arms 2614, 2616, 2618, and 2629are shown as being connected via sutures 2624, 2626, 2628, and 2629,which may be attached using a suture rail as described herein, it isunderstood that they can be secured to the native tissue by variousother appropriate means, such as barbed anchors, and/or microanchors,including using methods as described herein. In some embodiments, thebraided structure 2610 can comprise a first, inner braided layer and asecond, outer braided layer extending over the inner braided layer, theouter braided layer being relatively less porous to blood than the innerbraided layer.

In alternative embodiments, the support structure 2610 can omit thecentral hub 2612 and instead the adjacent inner ends of the arms 2614,2616, 2618, 2629 can be connected to each other to effectively form aring or inner surface that completely surrounds and seals against theouter surface of the prosthetic valve.

In alternative embodiments, a docking assembly can include greater orfewer arms and/or one or more of the arms 2614, 2616, 2618, and 2629 maybe positioned at other locations on or adjacent the mitral valveannulus.

FIG. 66 shows another exemplary docking assembly, indicated generally at2700 for docking a prosthetic heart valve 2702 comprising a frame 2704and prosthetic leaflets 2706, as described herein, using a solid sheetstructure secured in multiple locations around the annulus as supportstructure for the prosthetic valve. FIG. 65 is a top plan view of theassembly 2700, taken from a superior view of the mitral valve. Theassembly 2700 can comprise a woven or non-woven sheet of material 2710.In particular embodiments, the sheet 2710 comprises a sheet ofpolyethylene terephthalate (PET) fabric, although other woven ornon-woven synthetic materials (e.g., polyurethane) or natural tissue(e.g., pericardium) can be used.

The sheet 2710 can be sewn to the frame 2704 of the prosthetic heartvalve 2702. In particular embodiments, the sheet 2710 fully or at leastpartially surrounds the circumference of the frame 2704 of theprosthetic heart valve 2702, serving a function similar to a radialflange. In some embodiments, the sheet may be reinforced with wire, suchas nickel titanium (NiTi) wire to help it maintain its shape within theannulus. As shown in FIG. 66, the portion of the sheet 2710 adjacent tothe native anterior mitral valve leaflet 6 can be attached thereto via afirst suture 2712. The portion of the sheet 2710 adjacent to the nativeposterior mitral valve leaflet 8 can be attached thereto via a secondsuture 2714. These sutures 2712, 2714 are useful for retaining the valvein position between the two native leaflets 6, 8.

Extending from these first two sutures 2712, 2714 in the direction ofthe posteromedial commissure 7 is a first sheet section 2720. Firstsheet section 2720 can be attached at an end opposite the prostheticheart valve to the posteromedial commissure 7 via a third suture 2725.Extending from the first two sutures 2712, 2714 in the direction of theanterolateral commissure 9 is a second sheet section 2730. Second sheetsection 2730 can be attached at an end opposite the prosthetic heartvalve to the anterolateral commissure 9 via a fourth suture 2735. Thethird and fourth sutures 2725, 2735 are useful for sealing the sheet2710 and valve assembly and minimizing blood flow around the prostheticheart valve 2702. In particular embodiments, and as shown, the distancebetween the locations on the native leaflets 6, 8 at which the first andsecond sutures 2712, 2714 are attached matches the outer diameter of theframe 2704 of the prosthetic heart valve 2702. In alternativeembodiments, the native leaflets 6, 8 may be “cinched” to the tablecloth2710 by suturing, e.g., by using the first two sutures 2712, 2714.

In some embodiments, the sheet sections 2720, 2730 can be separatepieces of materials secured (e.g., by sutures) at different locations tothe outer surface of the frame 2704. In other embodiments, the sheetsections 2720, 2730 can be sections of a larger, single, or unitary,sheet of material having an opening for receiving the prosthetic valve2702.

For any of the embodiments shown in FIGS. 60-66, unless otherwise statedthe sutures and the bodies can be delivered and implanted using any ofthe delivery devices and techniques described herein. In particularembodiments, for example, the suture rail delivery system shown in FIGS.21-31 can be used to implant each of the sutures. The delivery device1420 shown in FIGS. 42-45 can be used to deliver and implant each of thebodies. The prosthetic heart valve can be delivered and expanded withinthe bodies using a separate delivery catheter (such as shown in 55B)after the bodies are implanted within the native mitral valve.

General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods. Asused herein, the terms “a”, “an”, and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “Band C”, or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

We claim:
 1. An implantable assembly for a native heart valvecomprising: a prosthetic heart valve comprising a frame and prostheticleaflets; first and second inflatable bodies; wherein the firstinflatable body comprises first and second end portions, wherein thefirst end portion is configured to be secured to tissue of the nativeheart valve at a first location, and the second end portion isconfigured to engage an outer surface of the prosthetic heart valve; andwherein the second inflatable body comprises third and fourth endportions, wherein the third end portion is configured to be secured totissue of the native heart valve at a second location, and the fourthend portion is configured to engage the outer surface of the prostheticheart valve; wherein the first and second inflatable bodies anchor theprosthetic heart valve within the annulus of the native heart valve; andwherein one or both of the first and second inflatable bodies arepivotally connected to the prosthetic heart valve.
 2. The assembly ofclaim 1, wherein a cross-section of the first inflatable body comprisesa triangle.
 3. The assembly of claim 1, wherein a cross-section of thefirst inflatable comprises a trapezoid.
 4. The assembly of claim 1,wherein the second and fourth end portions are sutured to the prostheticheart valve.
 5. The assembly of claim 1, wherein the first and secondinflatable bodies each comprises an inflatable balloon and a braided orwoven outer layer covering the balloon.
 6. The assembly of claim 5,wherein the outer layer comprises polyethylene terephthalate (PET). 7.The assembly of claim 1, wherein the first and second inflatable bodiesare inflated with curable polymer.
 8. The assembly of claim 1, whereineach of the first and second inflatable bodies comprises a brackethaving a lower flange and an upper flange, the upper and lower flangesextending radially inward of the frame of the prosthetic heart valve. 9.The assembly of claim 1, further comprising sutures connected to thefirst and second inflatable bodies for securing the bodies to the tissueof the native heart valve.
 10. An implantable assembly for a nativeheart valve comprising: a prosthetic heart valve comprising a frame andprosthetic leaflets; first and second inflatable bodies; wherein thefirst inflatable body comprises first and second end portions, whereinthe first end portion is configured to be secured to tissue of thenative heart valve at a first location, and the second end portion isconfigured to engage an outer surface of the prosthetic heart valve; andwherein the second inflatable body comprises third and fourth endportions, wherein the third end portion is configured to be secured totissue of the native heart valve at a second location, and the fourthend portion is configured to engage the outer surface of the prostheticheart valve; wherein the first and second inflatable bodies anchor theprosthetic heart valve within the annulus of the native heart valve;wherein the first and second inflatable bodies each comprises aninflatable balloon and a braided or woven outer layer covering theballoon.
 11. The assembly of claim 10, wherein a cross-section of thefirst inflatable body comprises a triangle.
 12. The assembly of claim10, wherein the second and fourth end portions are sutured to theprosthetic heart valve.
 13. The assembly of claim 10, wherein the outerlayer comprises polyethylene terephthalate (PET).
 14. The assembly ofclaim 10, wherein the first and second inflatable bodies are inflatedwith curable polymer.
 15. The assembly of claim 10, further comprisingsutures connected to the first and second inflatable bodies for securingthe bodies to the tissue of the native heart valve.
 16. The assembly ofclaim 15, wherein the outer layer comprises polyethylene terephthalate(PET).
 17. An implantable assembly for a native heart valve comprising:a prosthetic heart valve comprising a frame and prosthetic leaflets;first and second inflatable bodies; and wherein the first inflatablebody comprises first and second end portions, wherein the first endportion is configured to be secured to tissue of the native heart valveat a first location, and the second end portion is configured to engagean outer surface of the prosthetic heart valve; and wherein the secondinflatable body comprises third and fourth end portions, wherein thethird end portion is configured to be secured to tissue of the nativeheart valve at a second location, and the fourth end portion isconfigured to engage the outer surface of the prosthetic heart valve;and sutures connected to the first and third end portions for securingthe bodies to the tissue of the native heart valve wherein the first andsecond inflatable bodies anchor the prosthetic heart valve within theannulus of the native heart valve.
 18. The assembly of claim 17, whereina cross-section of the first inflatable body comprises a triangle. 19.The assembly of claim 17, wherein the second and fourth end portions aresutured to the prosthetic heart valve.
 20. The assembly of claim 17,wherein the first and second inflatable bodies are inflated with curablepolymer.
 21. A method comprising: implanting first and second inflatablebodies within an annulus of a native heart valve; and implanting aprosthetic heart valve comprising a frame and prosthetic leafletsbetween the inflatable bodies such that the prosthetic heart valve isretained within the annulus by the inflatable bodies; wherein the firstinflatable body comprises first and second end portions, wherein thefirst end portion is configured to be secured to tissue of the nativeheart valve at a first location, and the second end portion isconfigured to engage an outer surface of the prosthetic heart valve; andwherein the second inflatable body comprises third and fourth endportions, wherein the third end portion is configured to be secured totissue of the native heart valve at a second location, and the fourthend portion is configured to engage the outer surface of the prostheticheart valve; wherein the first and second inflatable bodies anchor theprosthetic heart valve within the annulus of the native heart valve; andwherein one or both of the first and second inflatable bodies arepivotally connected to the prosthetic heart valve.
 22. The method ofclaim 21, wherein implanting the first and second inflatable bodiescomprises securing the inflatable bodies to tissue of the native heartvalve with sutures.
 23. The method of claim 21, wherein implanting thefirst and second inflatable bodies comprises delivering the bodies tothe annulus in a non-inflated state, positioning the bodies atrespective locations within the annulus, and introducing an inflationmedium into the bodies to inflate the bodies from the non-inflated stateto an inflated state.
 24. The method of claim 23, wherein introducingthe inflation medium into the bodies comprises injecting a curablepolymer in liquid form into the bodies.
 25. The method of claim 21,wherein implanting the first and second bodies comprises securing thebodies to the commissures of the native mitral valve.
 26. The method ofclaim 21, wherein each of the inflatable bodies comprises upper andlower flanges that extend radially inward of the frame of the prostheticvalve.
 27. The method of claim 21, wherein implanting the prostheticheart valve comprises delivering the prosthetic heart valve in aradially compressed state to a location between the first and secondbodies and radially expanding the prosthetic heart valve to an expandedstate.
 28. The method of claim 21, wherein the first and second bodiesand the prosthetic valve are pre-assembled and delivered together to theannulus of the native heart valve.
 29. The method of claim 21, whereineach of the first and second bodies comprises a polymeric inner layerand a braided or woven outer layer.